Overview

This trial is active, not recruiting.

Condition -postoperative pain
Treatments lfcnb, fnb
Sponsor University Hospital, Antwerp
Start date October 2011
End date August 2014
Trial size 210 participants
Trial identifier NCT02056145, 11/36/241

Summary

Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.
lfcnb
LFCNB - Normal Saline solution 10 cc
fnb
FNB - Normal saline solution 10 cc
(Active Comparator)
Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.
lfcnb
LFCNB - Normal Saline solution 10 cc
fnb
FNB - Chirocaine 0.25%, 20 cc
(Active Comparator)
Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.
lfcnb
LFCNB - Chirocaine 0.25%, 20 cc
fnb
FNB - Chirocaine 0.25%, 20 cc

Primary Outcomes

Measure
Use of opioids
time frame: 48 hours

Secondary Outcomes

Measure
Visual analog scale (VAS) scores (0-10)
time frame: 48 hours

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Primary hip arthroplasty with posterolateral approach. Exclusion Criteria: - Known allergy to levobupivacaine and / or piritramide - Known neurological disorders or peripheral neuropathies - Existing drug or alcohol abuse - Chronic use of pain medication (> started 3 months ago) not related to the hip suffering - Coagulopathy (international normalized ratio) > 1.4 - Thrombocytopenia <70,000 platelets, - Dementia - Pregnancy - Local infection hip - Hepatic and / or renal impairment - BMI> 45.

Additional Information

Principal investigator Sultan TEMURZIEV, MD
Description Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University Hospital, Antwerp.