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

Postoperative Pain Clinical Trial

Official title:

The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447429
• Other study ID #: 2020.7.2
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: July 2022
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Transversus abdominis plane block
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.

Drug:
• Placebo
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.

Locations

Country	Name	City	State
Turkey	Samsun Research and Training Hospital	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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 Endo — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operation time	operation time	time from first incision to last suture
Primary	visual analogue scale (VAS) scores	VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10	24th ours
Primary	postoperative analgesia doses	totally consumed analgesics	within 24 hours postoperatively
Secondary	Nausea and vomiting score	PONV (Postoperative nausea and vomiting) score calculated with PONV scale: score 0: no nausea or vomiting, score 1:mild nausea, not requesting medication, score 2: moderate nausea requesting medication, score 3: severe nausea and/or vomiting minimum:0 maximum:3	within 24 hours postoperatively
Secondary	first mobilization and flatus time	first mobilization and flatus time	within 24 hours postoperatively
Secondary	time of first opioid administration	time of first opioid administration	within 24 hours postoperatively