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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04634721
Other study ID # Ultrasound or Laparoscopic TAP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date January 15, 2021

Study information

Verified date January 2021
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 15, 2021
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

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.

Locations

Country Name City State
Turkey Ankara Sehir Hastanesi Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Total opioid usage amount of opioids used in perioperative period will be recorded 24 hours
Primary Mean postoperative static and dynamic numeric rating scale (NRS) at 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 Post operative nausea or vomiting instances of nausea or vomiting in the post operative period will be recorded 24 hours
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