Clinical trial NCT05447429: The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.
Official title: The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Postoperative Pain
Postoperative Nausea and Vomiting
Keywords: Sleeve gastrectomy
Transversus abdominis plane block
Postoperative pain management
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty patients had divided into two groups; TAP block group (TAP-B) and placebo (P) group. Every group contained 20 patients and randomization was performed by sealed envelope method. Patient and the data collector resident didn't know the which procedure was done thus single-blinded randomization were provided.
Primary purpose: TREATMENT

Brief summary: Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.

Detailed description: TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.

Eligibility criteria: Inclusion Criteria:

* patients between 18-65
* undergo Laparoscopic sleeve gastrectomy

Exclusion Criteria:

* Bupivacaine allergy
* having chronic pain or taking pain management
* ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or
* Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair

Primary outcomes:
measure: visual analogue scale (VAS) scores
timeFrame: 24th ours
measure: postoperative analgesia doses
timeFrame: within 24 hours postoperatively
Secondary outcomes:
measure: Nausea and vomiting score
timeFrame: within 24 hours postoperatively
measure: first mobilization and flatus time
timeFrame: within 24 hours postoperatively
measure: time of first opioid administration
timeFrame: within 24 hours postoperatively
Other outcomes:
measure: operation time
timeFrame: time from first incision to last suture
Locations:
city: Samsun
country: Turkey
facility: Samsun Research and Training Hospital
Study officials:
References:
citation: Coskun M, Yardimci S, Arslantas MK, Altun GT, Uprak TK, Kara YB, Cingi A. Subcostal Transversus Abdominis Plane Block for Laparoscopic Sleeve Gastrectomy, Is It Worth the Time? Obes Surg. 2019 Oct;29(10):3188-3194. doi: 10.1007/s11695-019-03984-4.
citation: Wong KA, Cabrera AG, Argiroff AL, Pechman DM, Parides MK, Vazzana JT, Moran-Atkin EM, Choi JJ, Camacho DR. Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial. Surg Obes Relat Dis. 2020 Jul;16(7):886-893. doi: 10.1016/j.soard.2020.03.031. Epub 2020 Apr 10.
citation: Saber AA, Lee YC, Chandrasekaran A, Olivia N, Asarian A, Al-Ayoubi S, DiGregorio R. Efficacy of transversus abdominis plane (TAP) block in pain management after laparoscopic sleeve gastrectomy (LSG): A double-blind randomized controlled trial. Am J Surg. 2019 Jan;217(1):126-132. doi: 10.1016/j.amjsurg.2018.07.010. Epub 2018 Aug 1.
citation: Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4.