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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02951520
Other study ID # REC 001
Secondary ID
Status Recruiting
Phase Phase 4
First received October 29, 2016
Last updated November 1, 2016
Start date October 2016

Study information

Verified date November 2016
Source Healthpoint Hospital
Contact Ahmad M Taha, MD
Phone 00971508297326
Email ahmadtaha_1@yahoo.com
Is FDA regulated No
Health authority United Arab Emirates: General Authority for Health Services for Abu Dhabi
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Arthroscopic Knee Ligament Reconstruction

Intervention

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.

Locations

Country Name City State
United Arab Emirates Healthpoint Hospital Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
Healthpoint Hospital

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary success rate within the perioperative period No