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Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair

Primary Purpose

Postoperative Pain, Ultrasound Guided Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided quadratus lumborum block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I or II, scheduled for unilateral inguinal hernia repair

Exclusion Criteria:

  • Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation abnormities, renal or hepatic insufficiency, infection at the injection site, strangulated hernia and hypersensitivity to the local anesthetics

Sites / Locations

  • Abeer Ahmed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (original QLB-2):

Group B (trans-muscular OLB-3)

Arm Description

Local anesthetic will be injected between the quadratus lumborum muscle and the latissimus dorsi muscle guided by ultrasound.

Local anesthetic will be injected between quadratus lumborum and psoas major after passing through the quadratus lumborum muscle guided by ultrasound.

Outcomes

Primary Outcome Measures

duration of block

Secondary Outcome Measures

Full Information

First Posted
May 4, 2018
Last Updated
January 7, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03526731
Brief Title
Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair
Official Title
Quadratus Lumborum Block for Postoperative Pain Control in Patients Undergoing Unilateral Inguinal Hernia Repair, a Comparative Study Between Two Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
A significant component of pain experienced after abdominal surgery is related to incision of the abdominal wall and adequate analgesia can be a challenge. The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle where Local anesthetics can be injected. This technique provide analgesia after abdominal surgery due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space where lateral and anterior cutaneous branches from Th7 to L1 can be blocked . This was proved by Carney et al. who found traces of contrast agent in the TPVS following application of this block A novel USG QL block is the transmuscular approach which relies on clearly identifiable sonographic bony landmarks, Where the needle is advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA is finally injected between the QL and Psoas major (PM) muscle. The transmuscular QL block does not result in redundant antero-lateral spread of the injectate. This may indicate that lower volumes of LA potentially can be used and yet provide extensive thoracolumbar anesthesia. This study was designed to compare the duration of analgesia provided by the original QLB and transmuscular QLB in patients undergoing surgical repair of unilateral inguinal hernia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (original QLB-2):
Arm Type
Experimental
Arm Description
Local anesthetic will be injected between the quadratus lumborum muscle and the latissimus dorsi muscle guided by ultrasound.
Arm Title
Group B (trans-muscular OLB-3)
Arm Type
Experimental
Arm Description
Local anesthetic will be injected between quadratus lumborum and psoas major after passing through the quadratus lumborum muscle guided by ultrasound.
Intervention Type
Other
Intervention Name(s)
ultrasound guided quadratus lumborum block
Intervention Description
ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
Primary Outcome Measure Information:
Title
duration of block
Time Frame
immediately after the end of LA injection till patients pain complaint (VAS > 3) over a period of 24 hours postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I or II, scheduled for unilateral inguinal hernia repair Exclusion Criteria: Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation abnormities, renal or hepatic insufficiency, infection at the injection site, strangulated hernia and hypersensitivity to the local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed, MD
Organizational Affiliation
Faculty of Medicine - Cairo University _ Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abeer Ahmed
City
Cairo
ZIP/Postal Code
002211
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Citations:
PubMed Identifier
31623572
Citation
Ahmed A, Fawzy M, Nasr MAR, Hussam AM, Fouad E, Aboeldahb H, Saad D, Osman S, Fahmy RS, Farid M, Waheb MM. Ultrasound-guided quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia repair, a comparative study between two approaches. BMC Anesthesiol. 2019 Oct 17;19(1):184. doi: 10.1186/s12871-019-0862-z.
Results Reference
derived

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Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair

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