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Ultrasound Guided Anterior Quadratus Lumborum Block

Primary Purpose

Postoperative Pain, Ultrasound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Morphine Sulfate
Group P
Group A
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 Postoperative Pain focused on measuring quadratus lumborum block, pain, ultrasound, percutaneous nephrolithotomy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy

Exclusion Criteria:

  • Previous history of opioid use preoperatively,

    • Allergy to local anesthetics,
    • The presence of any systemic infection,

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

Group A

Group P

Arm Description

Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine)

Group P:PCA (morphine)

Outcomes

Primary Outcome Measures

Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)

Secondary Outcome Measures

morphine consumption
morphine consumption
side effect profile
side effect profile (Nausea and vomiting scale,Hypotension,Ramsay Sedation Scale) Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered. Hypotension Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap )
additional analgesic use
additional analgesic use

Full Information

First Posted
February 1, 2018
Last Updated
November 20, 2018
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03425162
Brief Title
Ultrasound Guided Anterior Quadratus Lumborum Block
Official Title
Ultrasound Guided Anterior Quadratus Lumborum Block for Postoperative Pain After Percutaneous Nephrolithotomy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
August 18, 2018 (Actual)
Study Completion Date
August 18, 2018 (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
Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime. This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.
Detailed Description
Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain. In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.Analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Ultrasound
Keywords
quadratus lumborum block, pain, ultrasound, percutaneous nephrolithotomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine)
Arm Title
Group P
Arm Type
Sham Comparator
Arm Description
Group P:PCA (morphine)
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
Morphine
Intervention Description
patient-controlled analgesia (PCA) morphine
Intervention Type
Procedure
Intervention Name(s)
Group P
Intervention Description
Group P:patient-controlled analgesia (PCA) morphine
Intervention Type
Procedure
Intervention Name(s)
Group A
Other Intervention Name(s)
Bupivacaine
Intervention Description
Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
morphine consumption
Description
morphine consumption
Time Frame
Postoperative 24 hours
Title
side effect profile
Description
side effect profile (Nausea and vomiting scale,Hypotension,Ramsay Sedation Scale) Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered. Hypotension Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap )
Time Frame
Postoperative 24 hours
Title
additional analgesic use
Description
additional analgesic use
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy Exclusion Criteria: Previous history of opioid use preoperatively, Allergy to local anesthetics, The presence of any systemic infection,
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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Ultrasound Guided Anterior Quadratus Lumborum Block

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