Selective Block of the Axillary Nerve in Postoperative Pain Management
|ClinicalTrials.gov Identifier: NCT01463865|
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : March 20, 2015
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.
|Condition or disease||Intervention/treatment|
|Pain, Postoperative||Drug: ropivacaine Drug: Sodium chloride|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial|
|Study Start Date :||November 2011|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
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
Other Name: Naropin
- Morphine consumption [ Time Frame: 0-4 hours postoperatively ]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 ]Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
- Total morphine consumption [ Time Frame: 0-24 hours postoperatively ]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 ]Postoperative nausea evaluated on a 1-3 scale with and without vomiting
- Escape block [ Time Frame: 0-4 hours postoperatively ]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 ]Number of morphine boli administered during the first 4 hours postoperatively
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463865