Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

April 4, 2024 updated by: Serap Diker, Ankara City Hospital Bilkent

Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?

Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Secondary aim is to compare complication rates of the two techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients included in the study will be randomized into two groups (group L and group P) in the preoperative period. Following routine anesthesia induction TAP block will be applied to group L patients with the lateral approach technique, and to group P patients with the posterior approach technique. Regional block complications will be recorded.

Standard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. The pain intensity of the patients will be questioned and VAS values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankay
      • Ankara, Cankay, Turkey
        • Ankara City Hospital,Bilkent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASAI-III patients undergoing laparoscopic nephrectomy
  • 18<BMI<40

Exclusion Criteria:

  • infection at the block site
  • coagulation disorder
  • pregnancy
  • kidney failure
  • liver failure
  • heart failure
  • allergy to local anesthetics
  • patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group L
Lateral transversus abdominis plane(TAP) block
Procedure: lateral tap block
In the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.
Active Comparator: Group P
Posterior transversus abdominis plane block
Procedure: posterior tap block
In the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain scale 0
Time Frame: at the PACU arrival
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
at the PACU arrival
Visual analog pain scale 1
Time Frame: Postoperative first hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative first hour
Visual Analog Pain scale 2
Time Frame: Postoperative second hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative second hour
Visual analog pain scale 6
Time Frame: Postoperative sixth hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative sixth hour
Visual Analog Pain scale 12
Time Frame: Postoperative 12. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative 12. hour
Visual Analog Pain scale 18
Time Frame: Postoperative18. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative18. hour
Visual Analog Pain scale 24
Time Frame: Postoperative 24. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Postoperative 24. hour
opioid comsuption
Time Frame: Within 24 hours postoperatively
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Within 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: MİYASE SERAP DİKER, DOCTOR, Ankara City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-21-1814

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain, Acute

Clinical Trials on lateral tap block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe