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NCT Number: NCT04634721

Transversus Abdominis Plan Block, 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.

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Key information

Conditions

Bupivacaine Anesthetics Anesthetics, Local Peripheral Nervous System Agents

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Şehir Hastanesi

Ankara, Çankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine injected . This will then be repeated on the contralateral side.

Primary outcomes

  1. 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.)

Secondary outcomes

  1. Post operative nausea or vomiting

    Time frame: 24 hours

    instances of nausea or vomiting in the post operative period will be recorded

Other outcomes

  1. Total opioid usage

    Time frame: 24 hours

    amount of opioids used in perioperative period will be recorded

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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