NCT02951520

Brief Summary

This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery.

Trial Health

55
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

October 29, 2016

Last Update Submit

November 1, 2016

Conditions

Arthroscopic Knee Ligament Reconstruction

Keywords

Patients

Outcome Measures

Primary Outcomes (1)

  • success rate

    within the perioperative period

Study Arms (1)

SOFT block

EXPERIMENTAL

Fifty patients will form the study group (one group). All the patients will receive supine ultrasound guided (US) sciatic, obturator, femoral nerve block technique using a single skin puncture (SOFT block).

Procedure: new technique for lower limb nerve blocks using a single skin puncture (SOFT block)

Interventions

new technique for lower limb nerve blocks using a single skin puncture (SOFT block)PROCEDURE

The patients will be in supine position. The block needle will be inserted at the inguinal crease (medial to the femoral vein) and advanced towards the femoral nerve, then redirected towards the obturator nerve (deep to the pectineus muscle). Lastly, it will be redirected posteriorly towards the sciatic nerve (deep to the quadratus femoris muscle). A ropivacaine-lidocaine-epinephrine mixture will be used to block these nerves. The block success rate (painless surgery), performance time and patient discomfort will be recorded.

SOFT block

Eligibility Criteria

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

You may qualify if:

  • Adult patients scheduled for arthroscopic knee ligament reconstruction

You may not qualify if:

  • BMI \> 30 kg.m-2,
  • ASA physical state \>II
  • Allergy to the used local anesthetics
  • Infection at the injection site
  • age \<18y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthpoint Hospital

Abu Dhabi, Abu Dhabi Emirate, 112308, United Arab Emirates

RECRUITING

Central Study Contacts

Ahmad M Taha, MD

CONTACT

00971508297326ahmadtaha_1@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of anesthesia

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2017

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

AE(1)