Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.

Official Title
-----------------
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial

Conditions
-----------------
Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Placebo
* Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip replacement Exclusion Criteria: general anaesthesia Allergy to local anesthetics of the amide type Revision surgery Bilateral surgery Chronic pain patient Women in the fertile age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided. | Drug: Ropivacaine<br> <br> * Other names: Naropin;Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively<br> <br> |
| Placebo Comparator: Placebo<br>8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided | Drug: Placebo<br> <br> * Other names: Saline, NaCl;Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-score 4 hours postoperative during movement | VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain. | 4 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-score 0-24 hours postoperative during movement | VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain. | 0-24 hours postoperatively | 
| VAS-score 0-24 hours postoperative at rest | VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain. | 0-24 hours postoperatively | 
| Oxynorm consumption | Oxynorm consumption 24 hours postoperative | 0-24 hours postoperative | 
| time to first oxynorm requirement |  | 0-24 hours postoperatively | 
| Mobilization | time to first mobilization | 0-24 hours postoperatively | 
| Mobilization | Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized | 0-24 hours postoperatively | 
| Length of stay |  | 0-7 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis