The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.

NCT05447429 | Completed

• 1 other identifier: 2020.7.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Postoperative Pain; Postoperative Nausea and Vomiting

Keywords

Sleeve gastrectomy; Transversus abdominis plane block; Postoperative pain management

Outcome Measures

Primary Outcomes (2)

• visual analogue scale (VAS) scores

  VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10

  24th ours

• postoperative analgesia doses

  totally consumed analgesics

  within 24 hours postoperatively

Secondary Outcomes (3)

• Nausea and vomiting score

  within 24 hours postoperatively

• first mobilization and flatus time

  within 24 hours postoperatively

• time of first opioid administration

  within 24 hours postoperatively

Other Outcomes (1)

• operation time

  time from first incision to last suture

Study Arms (2)

TAP Block

EXPERIMENTAL

In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml .

Procedure: Transversus abdominis plane block

Placebo

PLACEBO COMPARATOR

In this group , 20 ml saline solution will injected into the transversus abdominis plane.

Drug: Placebo

Interventions

Transversus abdominis plane block PROCEDURE

TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

TAP Block

Placebo DRUG

20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Placebo

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 between 18-65
• undergo Laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Training Hospital

Samsun, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31175560 BACKGROUND

• 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.

  PMID: 32402732 RESULT

• 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.

  PMID: 30170687 RESULT

• 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.

  PMID: 29869078 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sonmez Ocak,MD, Chief of residents

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 7, 2022
• Study Start: October 1, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)