Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Official Title
-----------------
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator

Conditions
-----------------
Obturator Nerve Block, Total Hip Replacement

Intervention / Treatment
-----------------
* Drug: Bupivacaine-epinephrine
* Procedure: Sham block
* Procedure: Obturator nerve block
* Drug: Sodium Chloride 9mg/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for primary hip replacement in spinal anesthesia Age >= 18 years American Society of Anesthesiologists physical status classification score I-III Informed consent Exclusion Criteria: Lacking the ability to corporate Lacking the ability to speak danish Planned discharge on the same day of surgery Neuropathy of the lower extremities Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID) Contraindications for dexamethasone Chronic opioid demanding pain Pregnancy Allergy towards one or both investigatory medicinal products Active treatment with amiodarone Active treatment with verapamil Active treatment with corticosteroids

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: Obturator nerve block<br>Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL. | Drug: Bupivacaine-epinephrine<br>* Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.<br>Procedure: Obturator nerve block<br>* Postoperative obturator nerve block<br>|
| Placebo Comparator: Sham block<br>Postoperative sham-block with normal saline. | Procedure: Sham block<br>* Injection as for obturator nerve block, but with placebo<br>Drug: Sodium Chloride 9mg/mL<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid dose 0-12 hour after total hip replacement | Cumulated dose of opioid 0-12 hour after total hip replacement | 0-12 hour after completion of total hip replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated dose of opioid 12-18 hours after total hip replacement. |  | 12-18 hours after completion of total hip replacement | 
| Pain at rest at time of examination (numeric rating scale) |  | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | 
| Pain at passive 90-degree hip flexion (numeric rating scale) |  | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | 
| Worst pain during ambulation on the day of surgery |  | 5 hours after completion of total hip replacement | 
| Time from completion of surgery to first dose of opioid |  | 24 hours after completion of total hip replacement | 
| Intensity of nausea on time of examination (numeric rating scale) |  | 1, 2, 5, 7 and 24 hours after completion of total hip replacement | 
| Incidences of emesis 0-18 hours after total hip replacement. |  | 0-18 hours after completion of total hip replacement | 
| Cumulated dose of ondansetron 0-18 hours after total hip replacement |  | 0-18 hours after completion of total hip replacement | 
| Cumulated dose of droperidol 0-18 hours after total hip replacement |  | 0-18 hours after completion of total hip replacement | 
| Length of stay on post anesthesia care unit after completion of total hip replacement |  | 24 hours after completion of total hip replacement | 
| Length of stay on hospital after completion of total hip replacement |  | Up to 2 days | 
| Ability to ambulate 5 hours after surgery | Ability to sit, stand, walk with tall rollator and walk with crutches | 5 hours after completion of total hip replacement | 
| Motor control with operated leg | Physiotherapist evaluating motor control with operated leg during ambulation. | 5 hours after completion of total hip replacement | 
| Self-reported sleep quality the first night after total hip replacement | Self-reported sleep quality on a 3-point-scale: 2 = Undisturbed sleep; 1 = Sleep disturbed by other reasons than pain; 0 = Sleep disturbed by pain. | 24 hours after completion of total hip replacement | 
| Duration of spinal anesthesia | Time from end of operation until regain of normal sensibility on anterior femur. | 0-4 hours after completion of total hip replacement |