Clinical trial NCT03856788: Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
Official title: Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of 24 Hour Opioid Consumption
timeFrame: 24 Hours postoperative
Secondary outcomes:
measure: Amount of Intraoperative IV Opioid Consumption
timeFrame: average 2-3 Hours
measure: Number of Participants Asked Area of Pain on the Body After Surgery
timeFrame: 24 Hours postoperative
measure: Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery
timeFrame: 24 Hours postoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Brooklyn
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christina Jeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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citation: 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.
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.
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. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
citation: 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.
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. doi: 10.1177/0310057X1003800307.
citation: 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.