NCT04644562

Brief Summary

the investigatots hypothesized that by injection a larger volume and higher concentration of local anesthetic in lumbar erector spinae plane block could result in successful anesthesia in patient undergoing lower limb vascular surgery. ultrasound-guided lumbar erector spinae plane block in patient undergoing lower limb vascular surgery with higher concentration of local anesthetic to asses it is efficacy as a sole anesthetic technique, it is safety and efficacy in maintaining intraoperative hemodynamics, intra and postoperative pain control .

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 not_applicable

Timeline
Completed

Started Nov 2020

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

July 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

July 17, 2020

Last Update Submit

November 19, 2020

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • motor block block level

    motor power

    baseline, pre-intervention/procedure/surgery

Study Arms (1)

patients undergoing Lower Limb vascular Surgery

EXPERIMENTAL

Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery

Other: Erector Spinae plane block

Interventions

Erector Spinae plane blockOTHER

Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery

patients undergoing Lower Limb vascular Surgery

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- ASA II and III male and female patients undergoing lower limb vascular 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 and chronic treatment with opium, non-steroidal anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef univercity

Banī Suwayf, Benisuef, 62511, Egypt

RECRUITING

Study Officials

  • doaa rashwan, md

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

doaa rashwan, md

CONTACT

00201011270763doaa_rashwan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor Doaa Rashwan

Study Record Dates

First Submitted

July 17, 2020

First Posted

November 25, 2020

Study Start

November 20, 2020

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

EG(1)