Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Completed

CT.gov ID

NCT04634721

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

24.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bupivacaine Anesthetics, Local Anesthetics Peripheral Nervous System Agents	Drug: bupivacaine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Jan 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Post operative nausea or vomiting [24 hours]
instances of nausea or vomiting in the post operative period will be recorded

Other Outcome Measures

Total opioid usage [24 hours]
amount of opioids used in perioperative period will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Şehir Hastanesi	Ankara	Çankaya	Turkey

Sponsors and Collaborators

Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet sahap, Principal Investigator, Ankara City Hospital Bilkent

ClinicalTrials.gov Identifier:

NCT04634721

Other Study ID Numbers:

Ultrasound or Laparoscopic TAP

First Posted:

Nov 18, 2020

Last Update Posted:

Jan 28, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mehmet sahap, Principal Investigator, Ankara City Hospital Bilkent

TAP block

laparoscopy

laparoscopic cholecystectomy

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Jan 28, 2021