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Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Primary Purpose

Cholecystectomy, Postoperative Pain, Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol
Ultrasound guided Quadratus Lumborum block
Ultrasound guided placebo Quadratus Lumborum block
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy

Exclusion Criteria:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.

Sites / Locations

  • University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Grup B

Grup S

Arm Description

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Outcomes

Primary Outcome Measures

Visual Analog Pain Scale
Visual Analog Pain Scale was used for pain

Secondary Outcome Measures

tramadol consumption
tramadol consumption
side effect profile scores)
side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
additional analgesic use
additional analgesic use

Full Information

First Posted
October 4, 2017
Last Updated
December 27, 2017
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03308955
Brief Title
Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery
Official Title
Analgesic Effect of Ultrasound Guided Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
December 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime. This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Postoperative Pain, Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective,randomized,single blind
Masking
Participant
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup B
Arm Type
Active Comparator
Arm Description
Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Arm Title
Grup S
Arm Type
Sham Comparator
Arm Description
Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided Quadratus Lumborum block
Intervention Description
Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided placebo Quadratus Lumborum block
Intervention Description
Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Primary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
Visual Analog Pain Scale was used for pain
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
tramadol consumption
Description
tramadol consumption
Time Frame
Postoperative 24 hours
Title
side effect profile scores)
Description
side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
Time Frame
Postoperative 24 hour
Title
additional analgesic use
Description
additional analgesic use
Time Frame
Postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy Exclusion Criteria: Previous history of opioid use preoperatively, Allergy to local anesthetics, The presence of any systemic infection, Uncontrolled arterial hypertension, Uncontrolled diabetes mellitus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, M.D
Organizational Affiliation
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
City
Bursa
Country
Turkey

12. IPD Sharing Statement

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Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

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