Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy

NCT06750627 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2708/UN14.2.2.VII.14/LT/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. The main questions it aims to answer are:

• Does continuous ESPB lower the intensity of postoperative pain compared to multimodal intravenous analgesia?
• Does continuous ESPB increase the time to first analgesic request?
• Does continuous ESPB reduce the amount of intravenous opioids required in the first 48 hours after surgery?
• Does continuous ESPB improve the overall recovery quality within 48 hours post-surgery? Participants will:
• Receive continuous ESPB or multimodal intravenous analgesia after the surgery.
• Undergo routine pain assessments, and recovery evaluations using tools like the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15).
• Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Conditions

Continuous Erector Spinae Plane Block; Unilateral Thoracotomy

Keywords

Erector Spinae Plane Block; Unilateral Thoracotomy; Regional Anesthesia; Continuous Peripheral Nerve Block

Outcome Measures

Primary Outcomes (4)

• Resting Pain Score 24 hours

  Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.

  24 hours

• Resting Pain Score 48 hours

  Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.

  48 hours

• Coughing Pain Score 24 hours

  Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.

  24 hours

• Coughing Pain Score 48 hours

  Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.

  48 hours

Secondary Outcomes (6)

• Time to First Analgesia

  48 hours

• Opioid Consumption 24 hours

  24 hours

• Opioid Consumption 48 hours

  48 hours

• Quality of Recovery Preoperative

  At enrollment

• Quality of Recovery 24 hours

  24 hours

Study Arms (2)

Continuous Erector Spinae Plane Block

ACTIVE COMPARATOR

Participants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive continuous ESPB for analgesia with USG guidance after the surgery. * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used is ketorolac, with dose of 30 mg every 8 hours * Paracetamol 1000 mg every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Procedure: Continuous Erector Spinae Plane Block

Multimodal Intravenous Analgesia

ACTIVE COMPARATOR

Participants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used will be ketorolac of 30 mg every 8 hours * Paracetamol 1g every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours. * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Drug: Multimodal Intravenous Analgesia

Interventions

Continuous Erector Spinae Plane Block PROCEDURE

Catheter are placed between the erector spinae muscle and the transversus processus with ultrasound guidance, blocking the dorsal and ventral ramus from the thorax and abdominal spinal nerves, at the level of T5. Local anesthesia is injected. Drugs used are Bupivacaine 0.25% with volume of 25 ml.

Also known as: ESPB

Continuous Erector Spinae Plane Block

Multimodal Intravenous Analgesia DRUG

Multimodal intravenous analgesia refers to the use of multiple intravenous (IV) agents with different mechanisms of action to provide effective pain relief. The goal is to achieve synergistic effects that improve analgesia while minimizing the doses of individual drugs, thereby reducing side effects. This approach is often used in perioperative and acute pain management. Patient will receive combinations of opioid through Patient Controlled Analgesia (PCA) device, NSAIDs, and Paracetamol (Acetaminophen)

Multimodal Intravenous Analgesia

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 21-65 years of age
• Undergoing Unilateral Thoracotomy Operation

You may not qualify if:

• Patients with ASA Physical Status \> III
• Obese or Underweight Patients with BMI of less than 18.5 or more than 29.99
• Patients with contraindications to be given local anesthesia drugs
• Patients with contraindications to be given opioid drugs
• Patients refused to participate

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

RSUP Prof. dr. I.G.N.G. Ngoerah

Denpasar, Bali, 80113, Indonesia

Location

Related Publications (13)

• Moorthy A, Ni Eochagain A, Dempsey E, Wall V, Marsh H, Murphy T, Fitzmaurice GJ, Naughton RA, Buggy DJ. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial. Br J Anaesth. 2023 Jan;130(1):e137-e147. doi: 10.1016/j.bja.2022.07.051. Epub 2022 Sep 13.

  PMID: 36109206 BACKGROUND

• Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available.

  PMID: 37465231 BACKGROUND

• Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.

  PMID: 34301447 BACKGROUND

• Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

  PMID: 29746445 BACKGROUND

• Gupta R, Van de Ven T, Pyati S. Post-Thoracotomy Pain: Current Strategies for Prevention and Treatment. Drugs. 2020 Nov;80(16):1677-1684. doi: 10.1007/s40265-020-01390-0.

  PMID: 32876936 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Fawzi Hanna, M.E., Abdel Latif, S.A.M., Hussien Maamoon, R.M., Abdel-Mouty Taher, I.A.-A., 2024. Erector Spinae Plane Block for Postoperative Analgesia after Video-Assisted Thoracoscopic Surgery (VATS). QJM: An International Journal of Medicine 117, hcae070.062. https://doi.org/10.1093/qjmed/hcae070.062

  BACKGROUND

• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

  PMID: 30621377 BACKGROUND

• Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.

  PMID: 30113699 BACKGROUND

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

  PMID: 28188621 BACKGROUND

• Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.

  PMID: 30099210 BACKGROUND

• Briscoe JB, Caso R. Pain control after thoracic surgery begins in the operating room. J Thorac Dis. 2022 Aug;14(8):2745-2747. doi: 10.21037/jtd-22-968. No abstract available.

  PMID: 36071777 BACKGROUND

• Cao C, Zhu ZH, Yan TD, Wang Q, Jiang G, Liu L, Liu D, Wang Z, Shao W, Black D, Zhao Q, He J. Video-assisted thoracic surgery versus open thoracotomy for non-small-cell lung cancer: a propensity score analysis based on a multi-institutional registry. Eur J Cardiothorac Surg. 2013 Nov;44(5):849-54. doi: 10.1093/ejcts/ezt406. Epub 2013 Aug 15.

  PMID: 23956268 BACKGROUND

Study Officials

• Tjokorda Gde Agung Senapathi, Professor

  Udayana University

  STUDY DIRECTOR

Central Study Contacts

Jancolin Yani, Medical Doctor

CONTACT

+628128781619; jancolinyani@student.unud.ac.id

Steven Okta Chandra, Medical Doctor

CONTACT

+6282148198699; stevenokta@student.unud.ac.id

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

ID (1)