NCT04628689

Brief Summary

The aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries

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
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4

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

September 30, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

September 30, 2020

Last Update Submit

November 19, 2020

Conditions

Hip Surgeries

Outcome Measures

Primary Outcomes (1)

  • time to first request of analgesics

    Postoperative time to first request of analgesics (hours)

    Postoperative 24 hours

Study Arms (2)

Group 0.25% bupivacaine

ACTIVE COMPARATOR

30 ml 0.25% bupivacaine

Other: quadratus lumborum block by paraspinous sagittal shift approach

Group 0.375% bupivacaine

ACTIVE COMPARATOR

0.375% bupivacaine

Other: quadratus lumborum block by paraspinous sagittal shift approach

Interventions

quadratus lumborum block by paraspinous sagittal shift approachOTHER

quadratus lumborum block by paraspinous sagittal shift approach

Group 0.25% bupivacaineGroup 0.375% bupivacaine

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I and II undergoing hip surgery.

You may not qualify if:

  • Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy) allergic reaction to drugs. opium addiction, any drug or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef univercity

Banī Suwayf, Benisuef, 62511, Egypt

RECRUITING

Central Study Contacts

doaa rashwan

CONTACT

00201011270763doaa_rashwan@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor Doaa Rashwan

Study Record Dates

First Submitted

September 30, 2020

First Posted

November 13, 2020

Study Start

November 20, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)