A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries

November 1, 2016 updated by: Ahmad Muhammad Taha, Healthpoint Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Under aseptic technique, all the patients will receive US-guided femoral, obturator and sciatic nerve blocks using a single puncture point. All blocks will be performed by an expert anesthetist. The femoral nerve will be blocked lateral to the femoral artery. The obturator nerve will be blocked after it exits the obturator canal (deep to pectineus muscle). While the sciatic nerve will be blocked deep (posterior) to the inferior border of quadratus femoris muscle. The motor block of the femoral, obturator and sciatic nerves and sensory block of the lateral femoral cutaneous nerve (LFCN) will be assessed before shifting the patient to the operating room.

The performance time, patient discomfort, technique success rate, the associated successful LFCN block and any complication will be recorded by the assistant. All patients were assessed neurologically before discharge and during the physiotherapy visits for 3 weak after surgery.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients scheduled for arthroscopic knee ligament reconstruction

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOFT block
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate
Time Frame: within the perioperative period
within the perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthpoint Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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