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

Primary Purpose

Obesity, Morbid, Postoperative Pain, Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block
Placebo
Sponsored by
Samsun Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Sleeve gastrectomy, Transversus abdominis plane block, Postoperative pain management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsun Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAP Block

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

visual analogue scale (VAS) scores
VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10
postoperative analgesia doses
totally consumed analgesics

Secondary Outcome Measures

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
first mobilization and flatus time
first mobilization and flatus time
time of first opioid administration
time of first opioid administration

Full Information

First Posted
June 25, 2022
Last Updated
July 1, 2022
Sponsor
Samsun Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05447429
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Postoperative Pain, Postoperative Nausea and Vomiting
Keywords
Sleeve gastrectomy, Transversus abdominis plane block, Postoperative pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Experimental
Arm Description
In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml .
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this group , 20 ml saline solution will injected into the transversus abdominis plane.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual analogue scale (VAS) scores
Description
VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10
Time Frame
24th ours
Title
postoperative analgesia doses
Description
totally consumed analgesics
Time Frame
within 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Nausea and vomiting score
Description
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
Time Frame
within 24 hours postoperatively
Title
first mobilization and flatus time
Description
first mobilization and flatus time
Time Frame
within 24 hours postoperatively
Title
time of first opioid administration
Description
time of first opioid administration
Time Frame
within 24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
operation time
Description
operation time
Time Frame
time from first incision to last suture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsun Research and Training Hospital
City
Samsun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31175560
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.
Results Reference
background
PubMed Identifier
32402732
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.
Results Reference
result
PubMed Identifier
30170687
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.
Results Reference
result
PubMed Identifier
29869078
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.
Results Reference
result

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

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