Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

January 27, 2021 updated by: Mehmet sahap, Ankara City Hospital Bilkent

Transversus Abdominis Plan Block Applied in Laparoscopic Cholecystectomies Effective By Which Method: Ultrasound or Laparoscopic?

Abdominal wall blocks are frequently used as part of multimodal analgesia for pain control after abdominal surgery. There are studies using the Transversus Abdominis Plane Block for postoperative pain control in laparoscopic cholecystectomies.

In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and laparoscopy during surgery.In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and LAPAROSCOPY during surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 60 patients aged 18-65, ASA 1-2-3, who will undergo elective laparoscopic cholecystectomy in our hospital, will be included in the study. Patients will be randomly divided into 3 groups with ultrasound (USG) guided (GROUP 1: USG) , Laparoscopic application (GROUP 2: LAP) and GROUP 3 :No-TAP blok Each group consists of 20 evil people. Written consent will be obtained by explaining the procedure to be performed before the operation to the patients. The Transversus Abdominis Plan Block will be applied to the patients by a blind anesthesiologist according to their group. The block to be made by the anesthesiologist who will apply the block procedure will be given in a closed envelope.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey
        • Ankara Sehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I,II,III
  • Patients 18-65
  • laparoscopic cholecystectomy

Exclusion Criteria:

  • ASA III higher
  • history of pain relief medication dependence
  • history of substance abuse
  • end stage chronic kidney disease
  • advanced liver disease
  • history of chronic pain -history of taking opioids or neuropathic agents regularly prior to surgery-
  • BMI of 50 or over
  • skin infections at the site of TAP block injection or port sites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic TAP block
Laparoscopic assisted TAP block will be done by surgeon intra-operatively
Drug: bupivacaine
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine injected . This will then be repeated on the contralateral side.
Active Comparator: Ultrasaund TAP block
injecting bupivacaine in transversus abdominis plane to block the somatic nerves
Drug: bupivacaine
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine injected . This will then be repeated on the contralateral side.
No Intervention: no TAP block
no TAP block would be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
Time Frame: 24 hours
o compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between three groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative nausea or vomiting
Time Frame: 24 hours
instances of nausea or vomiting in the post operative period will be recorded
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid usage
Time Frame: 24 hours
amount of opioids used in perioperative period will be recorded
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultrasound or Laparoscopic TAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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