Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

Not Applicable

Completed

• Conditions: Bupivacaine; Anesthetics, Local; Anesthetics; Peripheral Nervous System Agents
• Interventions: Drug: bupivacaine

• Registration Number: NCT04634721
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

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 Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Primary Completion: 2020-12-15
• Status Verified: 2021-01
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasaund TAP block	bupivacaine	injecting bupivacaine in transversus abdominis plane to block the somatic nerves
Laparoscopic TAP block	bupivacaine	Laparoscopic assisted TAP block will be done by surgeon intra-operatively

Primary Outcome Measures

Name	Time	Method
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours	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 Outcome Measures

Name	Time	Method
Post operative nausea or vomiting	24 hours	instances of nausea or vomiting in the post operative period will be recorded

Trial Locations

Locations (1)

Ankara Şehir Hastanesi; 🇹🇷 Ankara, Çankaya, Turkey