Selective Block of the Axillary Nerve in Postoperative Pain Management
Recruitment status was Recruiting
In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.
It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial|
- Morphine consumption [ Time Frame: 0-4 hours postoperatively ] [ Designated as safety issue: No ]Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.
- Visual analogue scale (VAS) score [ Time Frame: 0-12 hours and 12-24 hours postoperatively ] [ Designated as safety issue: No ]Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
- Total morphine consumption [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: No ]The total amount of morphine administered during the first 24 hours postoperatively
- Postoperative nausea and vomiting (PONV) [ Time Frame: 0-4, 0-12 and 12-24 hours postoperatively ] [ Designated as safety issue: No ]Postoperative nausea evaluated on a 1-3 scale with and without vomiting
- Escape block [ Time Frame: 0-4 hours postoperatively ] [ Designated as safety issue: No ]The use of an escape block (interscalene brachial plexus block) in patients with pain breakthrough despite IV morphine 0-4 hours postoperatively.
- Bolus morphine 5 mg iv [ Time Frame: 0-4 hours postoperatively ] [ Designated as safety issue: No ]Number of morphine boli administered during the first 4 hours postoperatively
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Drug: Sodium chloride
Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
Active Comparator: ropivacaine
Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463865
|Contact: Christian Rothe, MDemail@example.com|
|Sub-Investigator: Morten Jenstrup, MD|
|Sub-Investigator: Jørgen Lund, MD|
|Principal Investigator: Christian Rothe, MD|