Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block

September 24, 2017 updated by: Merve Kacan, Kecioren Education and Training Hospital

Comparison of Quadratus Lumborum Block and Transversus Abdominis Plane Block for Postoperative Pain Control After Laparoscopic Cholecystectomy

In this study, investigators aimed to compare the Quadratus Lumborum Block and the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After ethical committee approval, informed written consent will be obtained from all patients.

A Sample size of 60 patients (30 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective laparoscopic cholecystectomy under general anesthesia will be randomized to receive bilateral QLB or TAP before the surgery. The dose of local anesthetic in both groups will be 20 ml 0.25% Bupivacaine. Allocation to either group will be done using permuted block randomization method.

Patients will be taken to the block room 1 hour before surgery. ECG, NIBP and SpO2 monitor will be done. The IV access route will be provided. The patient will be given 0.03 mg / kg IV midazolam for routine premedication. Block will be applied by a blind anesthetist to the other data of the study. Under ultrasound guidance a 22 Gauge Sonoplex needle will be used for both techniques. The calculated dose of local anesthetic will be injected bilaterally with intermittent aspiration. The spread of injectate will be seed on ultrasound.

The procedure time for both blocks will be recorded and 30 minutes after the procedure is completed, and the patient will be taken to the operation room. General anesthesia will be applied to the patient in the operation procedure in the standard procedure. Intraoperative heart rate and / or mean arterial pressure is increased to 20% of the basal value and 0.5 mcg / kg IV fentanyl will be added. 30 minutes before the end of operation, 1 mg IV paracetamol and NSAID (dexketoprofen) 50 mg IV will be administered to the patient before extubation. The patient will be infected with IV PCA in the morphine. PC 1 mg IV bolus dose will be adjusted to 10 minutes of locked-out period. In the postoperative period, 4 * 1 gr / 24 h IV paracetamol will be given to each patient.

All patients will be assessed postoperatively by a blinded investigator: in the post-anesthesia care unit and at 0, 2, 4, 6, 12 and 24 h postoperatively.

Study Type

Interventional

Enrollment (Anticipated)

60

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
      • Ankara, Turkey
        • Recruiting
        • Kecioren ETH
        • Contact:
        • Sub-Investigator:
          • handan gulec
        • Sub-Investigator:
          • berrin kosar
        • Sub-Investigator:
          • eyup horasanli
        • Principal Investigator:
          • merve kacan

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2-3
  • elective Laparoscopic cholecystectomy
  • 19-65 years
  • Written informed consent

Exclusion Criteria:

  • Patient refusal Local infection at the site of injection
  • Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system
  • Inability to use intravenous patient controlled analgesia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QLB: Quadratus lumborum block

QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL)

patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %
Procedure: quadratus lumborum block
QLB: Quadratus lumborum block : 20 mL of 0.25% bupivacaine will be administered between the quadratus lumborum and the psoas major muscle bilaterally in the lateral decubitus position
Other Names:
  • QLB
Active Comparator: TAP: transversus abdominis plan block

TAP: Transversus abdominis plane block (TAP)

patients will receive a bilateral TAP block using Bupivicaine 0.25%
Procedure: Transversus abdominis plan block
TAP: transversus abdominis plan block: 20 mL of 0.25% bupivacaine will be administered between the internal oblique muscle and the transversus abdominis muscle bilaterally in the supine position
Other Names:
  • TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cumulative morphine consumption
Time Frame: 24 hour
Total cumulative morphine dose in mg used in the first 24 hours after surgery
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of postoperative pain via visual analogue pain scale (VAS)
Time Frame: 24 hour
VAS range from 0 for no pain to 10 for worst pain imaginable
24 hour
Nausea or vomiting
Time Frame: 24 hour

0 = No Nausea

  1. = Mild Nausea.
  2. = Moderate 3 = Severe Nausea or Vomiting
24 hour

Collaborators and Investigators

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

Sponsor

Kecioren Education and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

April 20, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

September 12, 2018

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 24, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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