NCT03733769

Brief Summary

a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar plexus. The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4 transverse process level in saggital orientation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 6, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

November 6, 2018

Last Update Submit

January 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • peri-operative analgesia in hip Surgery

    post-operative VAS score

    one month

Study Arms (1)

TQL group

EXPERIMENTAL

transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery

Procedure: transmuscular quadratus lumborum block

Interventions

transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery

TQL group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral hip surgery.

You may not qualify if:

  • History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.
  • Patients with Body Mass Index (BMI) \<18.5 or \>30 kg/m2.
  • Coagulation disturbances (INR\>1.4, platelet count\<100 000).
  • History of opioid dependence (opioid use within the last 4 weeks).
  • History of allergies to study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21131, Egypt

Location

Related Publications (3)

  • Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.

    PMID: 30386022BACKGROUND
  • Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.

    PMID: 27730633BACKGROUND
  • Carline L, McLeod GA, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anaesth. 2016 Sep;117(3):387-94. doi: 10.1093/bja/aew224.

    PMID: 27543534BACKGROUND

Study Officials

  • Emad A Abdelmonem

    Alexandria faculty of medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of anaesthesiology

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

November 6, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

January 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations