NCT03502369

Brief Summary

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).

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 11, 2018

Last Update Submit

April 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Total amount of post operative morphine (mg).

    any time in the first 24 post operative hours.

Other Outcomes (1)

  • Patient satisfaction.

    every hour in the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.

Study Arms (2)

QL group

EXPERIMENTAL

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

C group

NO INTERVENTION

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.

Interventions

Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.

Also known as: Transmuscular QL block, QL3
QL group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria faculty of medicine

Alexandria, 21519, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28154824BACKGROUND
  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Adult 90 orthopaedic patient ASA physical status \|-\|\|\| will be randomly allocated in two groups each one 45 patients, one group will receive the anterior quadratus lumborum block and the other group will not receive the block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registeral

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 18, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

De identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion.

Locations