Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

NCT03856788 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 18-1886
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

Conditions

Laparoscopic Sleeve Gastrectomy; Subcostal Transversus Abdominis Plane Block

Keywords

Randomized control trial; Subcostal transversus abdominis plane block; Laparoscopic sleeve gastrectomy; Regional anesthesia; Opioid consumption; Bariatrics

Outcome Measures

Primary Outcomes (1)

• Amount of 24 Hour Opioid Consumption

  Amount of intravenous (IV) opioid consumption within 24-hour period

  24 Hours postoperative

Secondary Outcomes (3)

• Amount of Intraoperative IV Opioid Consumption

  average 2-3 Hours

• Number of Participants Asked Area of Pain on the Body After Surgery

  24 Hours postoperative

• Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery

  24 Hours postoperative

Study Arms (2)

Saline

PLACEBO COMPARATOR

Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.

Drug: Saline

Bupivacaine

ACTIVE COMPARATOR

Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.

Drug: Bupivacaine

Interventions

Saline DRUG

40 mL sterile normal saline

Saline

Bupivacaine DRUG

40 mL 0.25% bupivacaine

Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Adults 18-80 years old
• Candidate for general anesthesia
• Undergoing laparoscopic sleeve gastrectomy
• Patients of participating surgeons

You may not qualify if:

• Prior bariatric surgery of any kind
• Previous abdominoplasty
• Allergy or intolerance to one of the study medications
• ASA \> 4
• Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of \>5mg/day for one month)
• History of alcohol/drug abuse
• History of hepatic or renal insufficiency
• Patient refusal

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Brooklyn

New York, New York, 11217, United States

Location

Related Publications (10)

• Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.

  PMID: 26943657 BACKGROUND

• Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.

  PMID: 27177956 BACKGROUND

• Cho JS, Kim HI, Lee KY, Son T, Bai SJ, Choi H, Yoo YC. Comparison of the effects of patient-controlled epidural and intravenous analgesia on postoperative bowel function after laparoscopic gastrectomy: a prospective randomized study. Surg Endosc. 2017 Nov;31(11):4688-4696. doi: 10.1007/s00464-017-5537-6. Epub 2017 Apr 7.

  PMID: 28389801 BACKGROUND

• Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.

  PMID: 26955306 BACKGROUND

• Moncada R, Martinaitis L, Landecho M, Rotellar F, Sanchez-Justicia C, Bellver M, de la Higuera M, Silva C, Oses B, Martin E, Perez S, Hernandez-Lizoain JL, Fruhbeck G, Valenti V. Does Preincisional Infiltration with Bupivacaine Reduce Postoperative Pain in Laparoscopic Bariatric Surgery? Obes Surg. 2016 Feb;26(2):282-8. doi: 10.1007/s11695-015-1761-0.

  PMID: 26084250 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• Shibata Y, Sato Y, Fujiwara Y, Komatsu T. Transversus abdominis plane block. Anesth Analg. 2007 Sep;105(3):883; author reply 883. doi: 10.1213/01.ane.0000268541.83265.7d. No abstract available.

  PMID: 17717265 BACKGROUND

• Lee TH, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches to ultrasound-guided transversus abdominis plane block. Anaesth Intensive Care. 2010 May;38(3):452-60. doi: 10.1177/0310057X1003800307.

  PMID: 20514952 BACKGROUND

• Ari DE, Ar AY, Karip CS, Koksal C, Aydin MT, Gazi M, Akgun F. Ultrasound-guided subcostal-posterior transversus abdominis plane block for pain control following laparoscopic sleeve gastrectomy. Saudi Med J. 2017 Dec;38(12):1224-1229. doi: 10.15537/smj.2017.12.21133.

  PMID: 29209672 BACKGROUND

Related Links

• Subcostal TAP Block

MeSH Terms

Interventions

Sodium Chloride; Bupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Christina Jeng, MD, FASA
• Organization: Icahn School of Medicine at Mount Sinai

christina.jeng@mountsinai.org

212) 241-6426

Study Officials

• Christina Jeng, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: December 10, 2018
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: October 17, 2022
• Results First Posted: October 17, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)