Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:

Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856788
• Other study ID #: GCO 18-1886
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2018
• Est. completion date: March 25, 2021

Study information

• Verified date: September 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy
• Subcostal Transversus Abdominis Plane Block

Intervention

Drug:
• Saline
40 mL sterile normal saline
• Bupivacaine
40 mL 0.25% bupivacaine

Locations

Country	Name	City	State
United States	Mount Sinai Brooklyn	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Ari DE, Ar AY, Karip CS, Köksal C, Aydin MT, Gazi M, Akgün 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Moncada R, Martinaitis L, Landecho M, Rotellar F, Sanchez-Justicia C, Bellver M, de la Higuera M, Silva C, Osés B, Martín E, Pérez S, Hernandez-Lizoain JL, Frühbeck G, Valentí 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. — View Citation

Ruiz-Tovar J, Muñoz JL, Gonzalez J, Zubiaga L, García A, Jimenez M, Ferrigni C, Durán 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. — View Citation

Shibata Y, Sato Y, Fujiwara Y, Komatsu T. Transversus abdominis plane block. Anesth Analg. 2007 Sep;105(3):883; author reply 883. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of 24 Hour Opioid Consumption	Amount of intravenous (IV) opioid consumption within 24-hour period	24 Hours postoperative
Secondary	Amount of Intraoperative IV Opioid Consumption	Amount of intravenous opioid consumption during the surgery	average 2-3 Hours
Secondary	Number of Participants Asked Area of Pain on the Body After Surgery	Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery.	24 Hours postoperative
Secondary	Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery	Number of participants who answered yes to having presence of nausea after surgery	24 Hours postoperative

External Links

•   Subcostal TAP Block