Selective Block of the Axillary Nerve in Postoperative Pain Management

NCT01463865 | Completed

• 1 other identifier: H-1-2011-057
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Visual analogue scale (VAS) score

  0-12 hours and 12-24 hours postoperatively

• Total morphine consumption

  0-24 hours postoperatively

• Postoperative nausea and vomiting (PONV)

  0-4, 0-12 and 12-24 hours postoperatively

• Escape block

  0-4 hours postoperatively

• Bolus morphine 5 mg iv

  0-4 hours postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sodium chloride

Drug: Sodium chloride

ropivacaine

ACTIVE COMPARATOR

Naropin

Drug: ropivacaine

Interventions

ropivacaine DRUG

Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml

Also known as: Naropin

ropivacaine

Sodium chloride DRUG

Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead

Study Sites (1)

Aleris-Hamlet Hospital

Frederiksberg, Denmark

Location

Related Publications (2)

• 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.

  PMID: 21827442 BACKGROUND

• 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.

  PMID: 32005160 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research, Associate professor, phd

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 2, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

DK (1)