Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries

NCT06838026 | Not Yet Recruiting

• 1 other identifier: 20222023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare the safety and effectiveness of the three intercostal nerve blocks used in pain management in uniportal (one port) thoracoscopic surgeries: internal intercostal nerve blocks (ICNB), external ICNB, and Intercostal catheters. Participants will be randomly assigned to three groups:

• First group will undergo internal intercostal nerve block
• Second group will be given external intercostal nerve block
• Third group will have an intercostal catheter Researchers will compare the three groups to see their impact on post-operative pain management in uniportal VATS.

Conditions

Thoracic; Pain, Postoperative; Analgesia; Satisfaction, Patient

Keywords

Intercostal nerve block; Intercostal Catheter; Video-Assisted Thoracoscopic Surgery; Post-operative Pain; Patients' Satisfaction

Outcome Measures

Primary Outcomes (5)

• The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS

  To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 3 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 3 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  From participants enrollment until 3 hours after the surgery

• The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS

  To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 6 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 6 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  From participants enrollment until 6 hours after the surgery

• The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS

  To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 24 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 24 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  From participants enrollment until 24 hours after the surgery

• The effectiveness of the three approaches of pain management after uniportal VATS

  To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the participants' use of opioids, during the 24 hours post-operatively.

  From participants enrollment and during the 24 hours post-operatively

• The effectiveness of the three approaches of pain management after uniportal VATS, during different positions

  To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS, during coughing, deep breathing, lying down, moving and chest tube removal, through the use of NRS11, 24 hours post-operatively. The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at the three different positions. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  24 hours post-operatively

Secondary Outcomes (7)

• The effect of the three different approaches of pain management on post-operative hypoxemia

  From participants enrollment until 3 hours after the uniportal VATS

• The effect of the three different approaches of pain management on post-operative hypoxemia

  From participants enrollment until 6 hours after the uniportal VATS

• The effect of the three different approaches of pain management on post-operative hypoxemia

  From participants enrollment until 24 hours after the uniportal VATS

• The effect of the three different approaches of pain management on post-operative atelectasis

  From participants enrollment until 24 hours after the uniportal VATS

• The effect of the three different approaches of pain management on post-operative Pneumothorax

  From participants enrollment until 24 hours after the uniportal VATS

Study Arms (3)

External intercostal nerve block

EXPERIMENTAL

30 participants will be randomised for the External Intercostal block will receive a mixture of analgesics (Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%, through: Identifying the targeted intercostal spaces: The 3rd-7th by applying digital palpation and indentation of these spaces using the surgeon's fingers and the camera. After identifying the desired spaces, they will use 10 cc syringe connected to 23 Gauge needs, the needle will be applied externally into the chest wall, advancing it with negative pressure, making sure to keep the needle perpendicular to the chest wall to avoid injury to the intercostal neurovascular bundle, advancing the needle while keeping negative pressure, and being closer to the upper border of the ribs. Once the indentation of needle into the pleural is seen, they aspirate again to make sure that they are not into blood vessels, then they will inject 8 cc into each intercostal space.

Other: External Intercostal Nerve Block

Internal intercostal nerve block

ACTIVE COMPARATOR

30 participants will be randomised for the Internal Intercostal block will receive a mixture of analgesics (the investigators will use a mixture of local analgesics containing: Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%), through: -Using the blue color butterfly needle, 23 gauge, The needle will be introduced into the thoracic cavity under the thoracoscopic control and vision, Identification of the intercostal spaces: The third down to the seventh, total of 5 intercostal spaces, the needle will be introduced under vision into the intercostal spaces, avoiding the intercostal artery or veins, aspiration to make sure that they are not into blood vessels, then 10 injecting 8 cc of the analgesic mixture into each of the intercostal spaces, making sure to see the pleura over the intercostal space bulging to indicate that the analgesic is not injected into deeper muscular layers.

Other: Internal Intercostal Nerve Block

Intercostal catheter

ACTIVE COMPARATOR

30 Participants will be randomised for the Intercostal Catheter, the investigators will use an epidural catheter set, they will apply the catheter to one - two intercostal spaces higher that the VATS incision. The investigators will start by applying the needle from outside, into the desired intercostal space, once they see the indentation of the needle. They will inject 5 - 10 cc of normal saline to distend the intercostal space, then they will remove the stylet part and they will introduce the catheter, after making sure that there is at least 3 centimeter of the catheter into the intercostal space, they will remove the needle, making sure not to move the catheter, then they will tunnel the catheter under the skin for 2 cm , the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.

Other: Intercostal Catheter

Interventions

External Intercostal Nerve Block OTHER

External ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space from outside the chest wall.

Also known as: External ICNB

External intercostal nerve block

Internal Intercostal Nerve Block OTHER

Internal ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space inside the chest wall under direct thoracoscopic vision.

Also known as: Internal ICNB

Internal intercostal nerve block

Intercostal Catheter OTHER

Intercostal Catheter: it will be put 1-2 intercostal spaces above the VATS incision, and the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.

Intercostal catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.

You may not qualify if:

• Children - under the age of 18 or participants above the age of 80.
• Participants with chest wall infections and those with decorticated lungs will be excluded from the study.
• Participants with pre-existing chest pain or severe renal or hepatic dysfunction
• Participants with a history of psychiatric disorder or inability to understand the consent form or how to use a Numerical Rating Scale (NRS) for pain measurement
• Participants who have allergy to any of the given drugs, second thoracic surgery, participation in other clinical trials, obesity with body mass index\>35 kg/m2, intake of antiplatelet or anticoagulant agents, spinal deformity and severe bradycardia will also be excluded.
• Participants will be withdrawn from the study if the technical failure happened in the block or VATS procedure was converted to open procedure.

Sponsors & Collaborators

• Al-Quds University: lead
• Al-Ahli Hospital, Hebron: collaborator
• Saint Joseph Hospital, East Jerusalem: collaborator

Study Sites (2)

Saint Joseph Hospital

East Jerusalem, Palestinian Territories

Location

Al-Ahli Hospital

Hebron, Palestinian Territories

Location

Related Publications (38)

• Mehrotra M, D'Cruz JR, Bishop MA, Arthur ME. Video-Assisted Thoracoscopy. 2024 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532952/

  PMID: 30422547 BACKGROUND

• Kirby TJ, Mack MJ, Landreneau RJ, Rice TW. Initial experience with video-assisted thoracoscopic lobectomy. Ann Thorac Surg. 1993 Dec;56(6):1248-52; discussion 1252-3. doi: 10.1016/0003-4975(93)90661-z.

  PMID: 8267420 BACKGROUND

• Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. doi: 10.1016/S0003-4975(03)01219-0.

  PMID: 14759479 BACKGROUND

• Kim S, Bae CM, Do YW, Moon S, Baek SI, Lee DH. Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery. Thorac Cardiovasc Surg. 2021 Sep;69(6):564-569. doi: 10.1055/s-0040-1705152. Epub 2020 Mar 29.

  PMID: 32222960 BACKGROUND

• Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.

  PMID: 34739134 BACKGROUND

• Detterbeck FC. Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Ann Thorac Surg. 2005 Oct;80(4):1550-9. doi: 10.1016/j.athoracsur.2004.11.051.

  PMID: 16181921 BACKGROUND

• Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.

  PMID: 34779845 BACKGROUND

• Okmen K, Okmen BM, Uysal S. Serratus Anterior Plane (SAP) Block Used for Thoracotomy Analgesia: A Case Report. Korean J Pain. 2016 Jul;29(3):189-92. doi: 10.3344/kjp.2016.29.3.189. Epub 2016 Jul 1.

  PMID: 27413485 BACKGROUND

• Reyad RM, Shaker EH, Ghobrial HZ, Abbas DN, Reyad EM, Abd Alrahman AAM, Al-Demery A, Issak ERH. The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study. Eur J Pain. 2020 Jan;24(1):159-170. doi: 10.1002/ejp.1473. Epub 2019 Sep 6.

  PMID: 31433893 BACKGROUND

• Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.

  PMID: 18713924 BACKGROUND

• Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007.

  PMID: 18831499 BACKGROUND

• Abd-Elshafy SK, Abdallal F, Kamel EZ, Edwar H, Allah EA, Maghraby HHM, Sayed JA, Ali MS, Elkhayat H, Mahran GSK. Paravertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention. Pain Physician. 2019 May;22(3):271-280.

  PMID: 31151335 BACKGROUND

• Zhang X, Zhang C, Zhou X, Chen W, Li J, Wang H, Liu J. Analgesic Effectiveness of Perioperative Ultrasound-Guided Serratus Anterior Plane Block Combined with General Anesthesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2412-2422. doi: 10.1093/pm/pnaa125.

  PMID: 32488265 BACKGROUND

• Thangavel AR, Sethi S, Gupta V. Comparison of Continuous Wound Infusion versus Continuous Epidural Infusion in Upper Abdominal Surgery: Noninferiority Randomized Controlled Trial. Anesth Essays Res. 2019 Oct-Dec;13(4):676-682. doi: 10.4103/aer.AER_133_19. Epub 2019 Dec 16.

  PMID: 32009714 BACKGROUND

• Fusco P, Cofini V, Petrucci E, Scimia P, Fiorenzi M, Paladini G, Behr AU, Borghi B, Flamini S, Pizzoferrato R, Colafarina O, Di Francesco A, Tabacco T, Necozione S, Marinangeli F. Continuous wound infusion and local infiltration analgesia for postoperative pain and rehabilitation after total hip arthroplasty. Minerva Anestesiol. 2018 May;84(5):556-564. doi: 10.23736/S0375-9393.17.12110-3. Epub 2017 Oct 4.

  PMID: 28984095 BACKGROUND

• Tan JW, Mohamed JS, Tam JKC. Incorporation of an intercostal catheter into a multimodal analgesic strategy for uniportal video-assisted thoracoscopic surgery: a feasibility study. J Cardiothorac Surg. 2021 Jul 31;16(1):210. doi: 10.1186/s13019-021-01590-z.

  PMID: 34332605 BACKGROUND

• Mogahed MM, Elkahwagy MS. Paravertebral Block Versus Intercostal Nerve Block in Non-Intubated Uniportal Video-Assisted Thoracoscopic Surgery: A Randomised Controlled Trial. Heart Lung Circ. 2020 May;29(5):800-807. doi: 10.1016/j.hlc.2019.04.013. Epub 2019 May 9.

  PMID: 31147190 BACKGROUND

• Richardson J, Sabanathan S. Pain management in video assisted thoracic surgery: evaluation of localised partial rib resection. A new technique. J Cardiovasc Surg (Torino). 1995 Oct;36(5):505-9.

  PMID: 8522573 BACKGROUND

• Machino A, Wakamatsu M, Kaida T, Hirano H, Mori Y, Yamazaki S, Takahashi A, Haku S, Sugaya S, Kuroda K. [Postoperative pain management in video-assisted thoracic surgery using a continuous unilateral intercostal analgesia]. Masui. 2014 Dec;63(12):1319-23. Japanese.

  PMID: 25669083 BACKGROUND

• Kelly ME, Mc Nicholas D, Killen J, Coyne J, Sweeney KJ, McDonnell J. Thoracic paravertebral blockade in breast surgery: Is pneumothorax an appreciable concern? A review of over 1000 cases. Breast J. 2018 Jan;24(1):23-27. doi: 10.1111/tbj.12831. Epub 2017 May 30.

  PMID: 28557058 BACKGROUND

• Xiao W, Zhou W, Chen X, Zhu J, Xue Q, Shi J. Analgesic effect of intercostal nerve block given preventively or at the end of operation in video-assisted thoracic surgery: a randomized clinical trial. Braz J Anesthesiol. 2022 Sep-Oct;72(5):574-578. doi: 10.1016/j.bjane.2021.07.010. Epub 2021 Jul 26.

  PMID: 34324930 BACKGROUND

• Ahmed Z, Samad K, Ullah H. Role of intercostal nerve block in reducing postoperative pain following video-assisted thoracoscopy: A randomized controlled trial. Saudi J Anaesth. 2017 Jan-Mar;11(1):54-57. doi: 10.4103/1658-354X.197342.

  PMID: 28217054 BACKGROUND

• Ponholzer F, Ng C, Maier H, Dejaco H, Schlager A, Lucciarini P, Ofner D, Augustin F. Intercostal Catheters for Postoperative Pain Management in VATS Reduce Opioid Consumption. J Clin Med. 2021 Jan 19;10(2):372. doi: 10.3390/jcm10020372.

  PMID: 33478098 BACKGROUND

• Kadomatsu Y, Mori S, Ueno H, Uchiyama M, Wakai K. Comparison of the analgesic effects of modified continuous intercostal block and paravertebral block under surgeon's direct vision after video-assisted thoracic surgery: a randomized clinical trial. Gen Thorac Cardiovasc Surg. 2018 Jul;66(7):425-431. doi: 10.1007/s11748-018-0936-8. Epub 2018 May 8.

  PMID: 29740737 BACKGROUND

• Chen N, Qiao Q, Chen R, Xu Q, Zhang Y, Tian Y. The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial. J Clin Anesth. 2020 Feb;59:106-111. doi: 10.1016/j.jclinane.2019.07.002. Epub 2019 Jul 19.

  PMID: 31330457 BACKGROUND

• Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain. Ann Thorac Surg. 2000 Dec;70(6):1872-5. doi: 10.1016/s0003-4975(00)01757-4.

  PMID: 11156086 BACKGROUND

• Yim AP, Wan S, Lee TW, Arifi AA. VATS lobectomy reduces cytokine responses compared with conventional surgery. Ann Thorac Surg. 2000 Jul;70(1):243-7. doi: 10.1016/s0003-4975(00)01258-3.

  PMID: 10921716 BACKGROUND

• Cao C, Manganas C, Ang SC, Peeceeyen S, Yan TD. Video-assisted thoracic surgery versus open thoracotomy for non-small cell lung cancer: a meta-analysis of propensity score-matched patients. Interact Cardiovasc Thorac Surg. 2013 Mar;16(3):244-9. doi: 10.1093/icvts/ivs472. Epub 2012 Nov 20.

  PMID: 23169877 BACKGROUND

• Sun K, Liu D, Chen J, Yu S, Bai Y, Chen C, Yao Y, Yu L, Yan M. Moderate-severe postoperative pain in patients undergoing video-assisted thoracoscopic surgery: A retrospective study. Sci Rep. 2020 Jan 21;10(1):795. doi: 10.1038/s41598-020-57620-8.

  PMID: 31964955 BACKGROUND

• Bayman EO, Parekh KR, Keech J, Larson N, Vander Weg M, Brennan TJ. Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS. Pain Med. 2019 Mar 1;20(3):543-554. doi: 10.1093/pm/pny096.

  PMID: 29878248 BACKGROUND

• Piccioni F, Segat M, Falini S, Umari M, Putina O, Cavaliere L, Ragazzi R, Massullo D, Taurchini M, Del Naja C, Droghetti A. Enhanced recovery pathways in thoracic surgery from Italian VATS Group: perioperative analgesia protocols. J Thorac Dis. 2018 Mar;10(Suppl 4):S555-S563. doi: 10.21037/jtd.2017.12.86.

  PMID: 29629202 BACKGROUND

• Baldinelli F, Capozzoli G, Pedrazzoli R, Feil B, Pipitone M, Zaraca F. Are Thoracic Wall Blocks Efficient After Video-Assisted Thoracoscopy Surgery-Lobectomy Pain? A Comparison Between Serratus Anterior Plane Block and Intercostal Nerve Block. J Cardiothorac Vasc Anesth. 2021 Aug;35(8):2297-2302. doi: 10.1053/j.jvca.2020.09.102. Epub 2020 Sep 14.

  PMID: 33039288 BACKGROUND

• Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.

  PMID: 22531384 BACKGROUND

• Popping DM, Elia N, Van Aken HK, Marret E, Schug SA, Kranke P, Wenk M, Tramer MR. Impact of epidural analgesia on mortality and morbidity after surgery: systematic review and meta-analysis of randomized controlled trials. Ann Surg. 2014 Jun;259(6):1056-67. doi: 10.1097/SLA.0000000000000237.

  PMID: 24096762 BACKGROUND

• Zeltsman M, Dozier J, Vaghjiani RG, Poch A, Eguchi T, Pedoto A, Jones DR, Adusumilli PS. Decreasing use of epidural analgesia with increasing minimally invasive lobectomy: Impact on postoperative morbidity. Lung Cancer. 2020 Jan;139:68-72. doi: 10.1016/j.lungcan.2019.11.001. Epub 2019 Nov 11.

  PMID: 31743888 BACKGROUND

• Zhang X, Shu L, Lin C, Yang P, Zhou Y, Wang Q, Wu Y, Xu X, Cui X, Lin X, Jin L, Li T. Comparison Between Intraoperative Two-Space Injection Thoracic Paravertebral Block and Wound Infiltration as a Component of Multimodal Analgesia for Postoperative Pain Management After Video-Assisted Thoracoscopic Lobectomy: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1550-6. doi: 10.1053/j.jvca.2015.06.013. Epub 2015 Jun 10.

  PMID: 26409920 BACKGROUND

• Semyonov M, Fedorina E, Grinshpun J, Dubilet M, Refaely Y, Ruderman L, Koyfman L, Friger M, Zlotnik A, Klein M, Brotfain E. Ultrasound-guided serratus anterior plane block for analgesia after thoracic surgery. J Pain Res. 2019 Mar 11;12:953-960. doi: 10.2147/JPR.S191263. eCollection 2019.

  PMID: 30881105 BACKGROUND

• Wu CF, Hsieh MJ, Liu HP, Gonzalez-Rivas D, Liu YH, Wu YC, Chao YK, Wu CY. Management of post-operative pain by placement of an intraoperative intercostal catheter after single port video-assisted thoracoscopic surgery: a propensity-score matched study. J Thorac Dis. 2016 Jun;8(6):1087-93. doi: 10.21037/jtd.2016.04.01.

  PMID: 27293824 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yousef Abu Asabeh, M.D.

  Thoracic Surgery Department, Al-Ahli Hospital, Palestine

  STUDY CHAIR

• Mayar Idkedek, M.D.

  Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine

  STUDY DIRECTOR

• Tabarak Al-Masri, M.D.

  Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousef Abu Asabeh, M.D.

CONTACT

+972592949192; dryousefabuasbeh@gmail.com

Mayar Idkedek, M.D.

CONTACT

+972523172244; mayar.idkedek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be given the intercostal nerve block/ catheter directly after the completion of their uniportal VATS, and won't be aware which intervention was given to them in order to accurately measure the participants' level of satisfaction
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: February 20, 2025
• Study Start: May 5, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted starting 3 months and ending 5 years following article publication, extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial Sharing statement can be requested by qualified researchers engaging in scientific research, interested in the field of the trial, and whose proposed use of the data has been approved by an independent review committee. Access will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the corresponding author

Locations

PA (2)