Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty

A Comparative Study Between Two Approaches of Ultrasound-Guided Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty

The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.

Study Overview

• Status: Recruiting
• Conditions: Quadratus Lumborum Block
• Intervention / Treatment: Procedure: Quadratus lumborum Block

Detailed Description

During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain).

The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment.

Patients will be randomized to one of three equal groups:

• Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
• Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
• Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mai A nida, msc; Phone Number: +201012328193; Email: mai.nida90@gmail.com
• Study Contact Backup: Name: Mohammed Sh Elbrol, MD; Phone Number: +201063345623

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanata university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.

Exclusion Criteria:

• Patient refusal.
• Coagulopathy
• Spinal deformities
• Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
• Mental dysfunction, psychiatric illnesses and cognitive dysfunction.
• History of drug abuse &chronic analgesic use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group I: Control Group; Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.	Procedure: Quadratus lumborum Block; 1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.
Active Comparator: Group II:( transverse trans muscular Quadratus lumborum group).; patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.	Procedure: Quadratus lumborum Block; 1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.
Active Comparator: Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK; patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.	Procedure: Quadratus lumborum Block; 1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	Total Morphine consumption in the first 24 h of the post-operative period .	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	• Postoperative pain will be assessed by VAS (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 2,4,6,12,18,24 hours. If the VAS is 4 or more, 3 mg of intravenous morphine will be given as a rescue analgesia.	Baseline

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Chair: YASSER M RAGHEB, PROF, TANYAU

Publications and helpful links

General Publications

• Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
• Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 16, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 23, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: QL block on hip arthroplasty

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No