Selective Block of the Axillary Nerve in Postoperative Pain Management

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463865
• Other study ID #: H-1-2011-057
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: March 19, 2015
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• ropivacaine
Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml
• Sodium chloride
Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%

Locations

Country	Name	City	State
Denmark	Aleris-Hamlet Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Total morphine consumption	The total amount of morphine administered during the first 24 hours postoperatively	0-24 hours postoperatively	No
Secondary	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	No
Secondary	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	No
Secondary	Bolus morphine 5 mg iv	Number of morphine boli administered during the first 4 hours postoperatively	0-4 hours postoperatively	No