Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty

Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty

The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Anterior Quadratus lamborum block

Detailed Description

Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21519
    • Recruiting
    • Alexandria Faculty of Medicine
    • Contact: moutaz Ghandour, professor; Phone Number: 01003363712; Email: moutaz.ghandour@alexmed.edu.eg
    • Principal Investigator: Abdullah Gaber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American society of anesthesiologists physical status |-||| , scheduled to undergo unilateral hip replacement via lateral approach.

Exclusion Criteria:

• patient refusal.
• History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.
• coagulation disorders.
• History of allergy to the study medication.
• Infection overlying the injection site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: QL group; Anterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound.	Procedure: Anterior Quadratus lamborum block; Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.; Other Names: Transmuscular QL block; QL3
NO_INTERVENTION: C group; Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity assessment	Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.	every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of post operative morphine (mg).	Total amount of post operative morphine (mg) used as rescue analgesia and the first time of its request.	any time in the first 24 post operative hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction.	Patient satisfaction with pain control will be assessed on a four point scale 1.Excellent 2.Good 3.fair 4.poor	every hour in the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
• Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 050108004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No