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

Sponsor
Samsun Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05447429
Collaborator
(none)
40
1
2
4.5
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversus abdominis plane block
  • Drug: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Feb 15, 2022
Actual Study Completion Date :
Feb 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAP Block

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

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.

Placebo Comparator: Placebo

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

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.

Outcome Measures

Primary Outcome Measures

  1. visual analogue scale (VAS) scores [24th ours]

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

  2. postoperative analgesia doses [within 24 hours postoperatively]

    totally consumed analgesics

Secondary Outcome Measures

  1. Nausea and vomiting score [within 24 hours postoperatively]

    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

  2. first mobilization and flatus time [within 24 hours postoperatively]

    first mobilization and flatus time

  3. time of first opioid administration [within 24 hours postoperatively]

    time of first opioid administration

Other Outcome Measures

  1. operation time [time from first incision to last suture]

    operation time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsun Research and Training Hospital Samsun Turkey

Sponsors and Collaborators

  • Samsun Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sonmez Ocak, Sonmez Ocak,MD, Chief of residents, Samsun Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05447429
Other Study ID Numbers:
  • 2020.7.2
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sonmez Ocak, Sonmez Ocak,MD, Chief of residents, Samsun Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022