Evaluation of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled Clinical Trial

NCT04368195 | Completed

• 1 other identifier: H-01-R-069
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study will help us in understanding the role of erector spinae block (ESPB) for postoperative pain control in patients undergoing upper GI laparoscopy surgeries. The surgeries included in this group include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair. Patients aged between 18 and 65 years, scheduled to undergo any upper GI laparoscopy surgeries with an ASA score of 1 or 2 will be included in the study. This is a prospective randomised controlled trial which will compare two groups receiving either erector spinae block or no block for postoperative pain control after upper GI laparoscopy surgeries

Conditions

Pain, Postoperative

Keywords

Erector spinae block; Upper GI laparoscopy; Pain

Outcome Measures

Primary Outcomes (1)

• NRS pain score at 18th hours

  Primary outcome measures at commencement of the study will be NRS pain score at 18th hours postoperatively both at rest and when coughing.

  18th hour

Secondary Outcomes (2)

• Analgesic consumption

  24 hours

• Adverse events

  24 hours

Other Outcomes (1)

• NRS pain score at other time intervals

  0-24 hours

Study Arms (2)

Control group

NO INTERVENTION

This group will not receive any regional block

Erector spinae block group

EXPERIMENTAL

This group will receive erector spinae block

Procedure: Erector spinae block

Interventions

Erector spinae block PROCEDURE

Erector Spinae Plane Block (ESPB) - first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries (10-12). In ESPB, local anesthetic is reported to be administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces.

Erector spinae block group

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18 and 65years, scheduled to undergo any upper GI laparoscopy surgeries with an ASA score of 1 or 2 will be included in the study. The surgeries included in this group include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair.
• Written informed consent for general anesthesia and all procedures will be obtained from all patients.

You may not qualify if:

• Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and conversion to open laparotomy will not be included in the study.

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (2)

Security Forces Hospital Program

Riyadh, 11, Saudi Arabia

Location

Security Forces Hospital

Riyadh, 11, Saudi Arabia

Location

Related Publications (18)

• Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.

  PMID: 29794943 RESULT

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 RESULT

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 RESULT

• Singla S, Mittal G, Raghav, Mittal RK. Pain management after laparoscopic cholecystectomy-a randomized prospective trial of low pressure and standard pressure pneumoperitoneum. J Clin Diagn Res. 2014 Feb;8(2):92-4. doi: 10.7860/JCDR/2014/7782.4017. Epub 2014 Feb 3.

  PMID: 24701492 RESULT

• Enes H, Semir I, Sefik H, Husnija M, Goran I. Postoperative pain in open vs. laparoscopic cholecystectomy with and without local application of anaesthetic. Med Glas (Zenica). 2011 Aug;8(2):243-8.

  PMID: 21849946 RESULT

• Shin HJ, Oh AY, Baik JS, Kim JH, Han SH, Hwang JW. Ultrasound-guided oblique subcostal transversus abdominis plane block for analgesia after laparoscopic cholecystectomy: a randomized, controlled, observer-blinded study. Minerva Anestesiol. 2014 Feb;80(2):185-93. Epub 2013 Oct 31.

  PMID: 24193176 RESULT

• Oksar M, Koyuncu O, Turhanoglu S, Temiz M, Oran MC. Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. J Clin Anesth. 2016 Nov;34:72-8. doi: 10.1016/j.jclinane.2016.03.033. Epub 2016 May 2.

  PMID: 27687350 RESULT

• Visoiu M, Cassara A, Yang CI. Bilateral Paravertebral Blockade (T7-10) Versus Incisional Local Anesthetic Administration for Pediatric Laparoscopic Cholecystectomy: A Prospective, Randomized Clinical Study. Anesth Analg. 2015 May;120(5):1106-1113. doi: 10.1213/ANE.0000000000000545.

  PMID: 25427288 RESULT

• Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.

  PMID: 22763903 RESULT

• 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 RESULT

• Aksu C, Gurkan Y. Ultrasound guided erector spinae block for postoperative analgesia in pediatric nephrectomy surgeries. J Clin Anesth. 2018 Mar;45:35-36. doi: 10.1016/j.jclinane.2017.12.021. Epub 2017 Dec 20. No abstract available.

  PMID: 29274546 RESULT

• Balaban O, Aydin T, Yaman M. Is ultrasound guided erector spinae plane block sufficient for surgical anesthesia in minor surgery at thoracal region? J Clin Anesth. 2018 Jun;47:7-8. doi: 10.1016/j.jclinane.2018.02.012. Epub 2018 Mar 6. No abstract available.

  PMID: 29522967 RESULT

• 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 RESULT

• Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.

  PMID: 28727597 RESULT

• Costache I, Sinclair J, Farrash FA, Nguyen TB, McCartney CJ, Ramnanan CJ, Goodwin SL. Does paravertebral block require access to the paravertebral space? Anaesthesia. 2016 Jul;71(7):858-9. doi: 10.1111/anae.13527. No abstract available.

  PMID: 27291614 RESULT

• Roue C, Wallaert M, Kacha M, Havet E. Intercostal/paraspinal nerve block for thoracic surgery. Anaesthesia. 2016 Jan;71(1):112-3. doi: 10.1111/anae.13358. No abstract available.

  PMID: 26684531 RESULT

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 RESULT

• Ul Huda A, Alshahrani AS, Yasir M, Sawilah A, Alharthi AAN. Erector spinae block reduces intraoperative and postoperative opioid consumption in patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled trial. Qatar Med J. 2024 Dec 26;2024(4):58. doi: 10.5339/qmj.2024.58. eCollection 2024.

  PMID: 39944209 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 29, 2020
• Study Start: December 30, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year

Locations

SA (2)