NCT05465967

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

July 7, 2022

Last Update Submit

July 23, 2022

Conditions

Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine consumption

    Total Morphine consumption in the first 24 h of the post-operative period .

    Baseline

Secondary Outcomes (1)

  • Postoperative pain score

    Baseline

Study Arms (3)

Group I: Control Group

SHAM COMPARATOR

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

Group II:( transverse trans muscular Quadratus lumborum group).

ACTIVE COMPARATOR

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

Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK

ACTIVE COMPARATOR

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

Interventions

Quadratus lumborum BlockPROCEDURE

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.

Group I: Control GroupGroup II:( transverse trans muscular Quadratus lumborum group).Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanata university hospital

Tanta, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20462458BACKGROUND

  • 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.

    PMID: 33437078BACKGROUND

Study Officials

  • YASSER M RAGHEB, PROF

    TANYAU

    STUDY CHAIR

Central Study Contacts

mai A nida, msc

CONTACT

+201012328193mai.nida90@gmail.com

Mohammed Sh Elbrol, MD

CONTACT

+201063345623

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 20, 2022

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

EG(1)