Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

NCT ID: NCT04634721

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-01-15

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.

Conditions

Bupivacaine; Anesthetics, Local; Anesthetics; Peripheral Nervous System Agents

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic TAP block

Laparoscopic assisted TAP block will be done by surgeon intra-operatively

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: 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.

Ultrasaund TAP block

injecting bupivacaine in transversus abdominis plane to block the somatic nerves

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: 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.

no TAP block

no TAP block would be done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Mehmet sahap

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Şehir Hastanesi

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ultrasound or Laparoscopic TAP

Identifier Type: -

Identifier Source: org_study_id