Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nervous System Agents; Anesthetics, Local; Bupivacaine; Anesthetics
• Intervention / Treatment: Drug: bupivacaine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey
      • Ankara Sehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative nausea or vomiting	instances of nausea or vomiting in the post operative period will be recorded	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid usage	amount of opioids used in perioperative period will be recorded	24 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopy; laparoscopic cholecystectomy; TAP block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Ultrasound or Laparoscopic TAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No