Selective Block of the Axillary Nerve in Postoperative Pain Management

Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Sodium chloride; Drug: ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark
    • Aleris-Hamlet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sodium chloride	Drug: Sodium chloride; Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
Active Comparator: ropivacaine; Naropin	Drug: ropivacaine; Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.	0-4 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) score	Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.	0-12 hours and 12-24 hours postoperatively
Total morphine consumption	The total amount of morphine administered during the first 24 hours postoperatively	0-24 hours postoperatively
Postoperative nausea and vomiting (PONV)	Postoperative nausea evaluated on a 1-3 scale with and without vomiting	0-4, 0-12 and 12-24 hours postoperatively
Escape block	The use of an escape block (interscalene brachial plexus block) in patients with pain breakthrough despite IV morphine 0-4 hours postoperatively.	0-4 hours postoperatively
Bolus morphine 5 mg iv	Number of morphine boli administered during the first 4 hours postoperatively	0-4 hours postoperatively

Collaborators and Investigators

• Sponsor: Hillerod Hospital, Denmark

Publications and helpful links

General Publications

• Rothe C, Asghar S, Andersen HL, Christensen JK, Lange KH. Ultrasound-guided block of the axillary nerve: a volunteer study of a new method. Acta Anaesthesiol Scand. 2011 May;55(5):565-70. doi: 10.1111/j.1399-6576.2011.02420.x.
• Rothe C, Lund J, Jenstrup MT, Steen-Hansen C, Lundstrom LH, Andreasen AM, Lange KHW. A randomized controlled trial evaluating the impact of selective axillary nerve block after arthroscopic subacromial decompression. BMC Anesthesiol. 2020 Jan 31;20(1):33. doi: 10.1186/s12871-020-0952-y.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: H-1-2011-057