Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

NCT04634721 | Completed

• 1 other identifier: Ultrasound or Laparoscopic TAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

TAP block; laparoscopy; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post operative nausea or vomiting

  24 hours

Other Outcomes (1)

• Total opioid usage

  24 hours

Study Arms (3)

Laparoscopic TAP block

ACTIVE COMPARATOR

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

Drug: bupivacaine

Ultrasaund TAP block

ACTIVE COMPARATOR

injecting bupivacaine in transversus abdominis plane to block the somatic nerves

Drug: bupivacaine

no TAP block

NO INTERVENTION

no TAP block would be done

Interventions

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.

Laparoscopic TAP block; Ultrasaund TAP block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I,II,III
• Patients 18-65
• laparoscopic cholecystectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Şehir Hastanesi

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 18, 2020
• Study Start: November 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)