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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03526731

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Ultrasound Guided Nerve Block	Other: ultrasound guided quadratus lumborum block	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Quadratus Lumborum Block for Postoperative Pain Control in Patients Undergoing Unilateral Inguinal Hernia Repair, a Comparative Study Between Two Approaches

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (original QLB-2): Local anesthetic will be injected between the quadratus lumborum muscle and the latissimus dorsi muscle guided by ultrasound.	Other: ultrasound guided quadratus lumborum block ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
Experimental: Group B (trans-muscular OLB-3) Local anesthetic will be injected between quadratus lumborum and psoas major after passing through the quadratus lumborum muscle guided by ultrasound.	Other: ultrasound guided quadratus lumborum block ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.

Arm

Intervention/Treatment

Experimental: Group A (original QLB-2):

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

Other: ultrasound guided quadratus lumborum block

ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.

Experimental: Group B (trans-muscular OLB-3)

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

Other: ultrasound guided quadratus lumborum block

ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.

Outcome Measures

Primary Outcome Measures

duration of block [immediately after the end of LA injection till patients pain complaint (VAS > 3) over a period of 24 hours postoperative.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abeer Ahmed	Cairo		Egypt	002211

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Abeer Ahmed, MD, Faculty of Medicine - Cairo University _ Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abeer Ahmed, MD, Assistant Professor of Anesthesia and SICU - Faculty of Medicine - Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT03526731

Other Study ID Numbers:

N-13-2016

First Posted:

May 16, 2018

Last Update Posted:

Jan 8, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Hernia, Inguinal

Study Results

No Results Posted as of Jan 8, 2019