Selective Block of the Axillary Nerve in Postoperative Pain Management

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: ropivacaine; Drug: Sodium chloride

• Registration Number: NCT01463865
• Lead Sponsor: Hillerod Hospital, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-31
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects undergoing arthroscopic shoulder surgery
• Age between 18 and 80 years
• ASA 1-3
• BMI between 18 and 35 kg/m2
• Subjects which have given their written informed consent

Exclusion Criteria

• Subjects unable to cooperate to the investigation
• Subjects not understanding or speaking danish
• Subjects allergic to intervention drugs
• Daily use of strong analgesics (morphine, oxycontine, ketogan)
• Alcohol or medicine misuse
• Failure of nerve block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	ropivacaine	Naropin
Placebo	Sodium chloride	Sodium chloride

Primary Outcome Measures

Name	Time	Method
Morphine consumption	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.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score	0-12 hours and 12-24 hours postoperatively	Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
Escape block	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.
Postoperative nausea and vomiting (PONV)	0-4, 0-12 and 12-24 hours postoperatively	Postoperative nausea evaluated on a 1-3 scale with and without vomiting
Total morphine consumption	0-24 hours postoperatively	The total amount of morphine administered during the first 24 hours postoperatively
Bolus morphine 5 mg iv	0-4 hours postoperatively	Number of morphine boli administered during the first 4 hours postoperatively

Trial Locations

Locations (1)

Aleris-Hamlet Hospital; 🇩🇰 Frederiksberg, Denmark