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Selective Block of the Axillary Nerve in Postoperative Pain Management

This study is currently recruiting participants.
Verified May 2012 by Hillerod Hospital, Denmark
Sponsor:
Information provided by (Responsible Party):
Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01463865
First received: October 31, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Pain, Postoperative
 Drug: ropivacaine
Drug: Sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 0-4 hours postoperatively ] [ Designated as safety issue: No ]
    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:
  • Visual analogue scale (VAS) score [ Time Frame: 0-12 hours and 12-24 hours postoperatively ] [ Designated as safety issue: No ]
    Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.

  • Total morphine consumption [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Postoperative nausea evaluated on a 1-3 scale with and without vomiting

  • Escape block [ Time Frame: 0-4 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of morphine boli administered during the first 4 hours postoperatively


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • ropivacaine
  • Naropin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463865

Contacts
Contact: Christian Rothe, MD 004561281800 postrothe@gmail.com

Locations
Denmark
Aleris-Hamlet Hospital Recruiting
Frederiksberg, Denmark
Sub-Investigator: Morten Jenstrup, MD            
Sub-Investigator: Jørgen Lund, MD            
Principal Investigator: Christian Rothe, MD            
Sponsors and Collaborators
Hillerod Hospital, Denmark
  More Information

Publications:

Responsible Party: Kai Henrik Wiborg Lange, Head of research, Associate professor, phd, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01463865     History of Changes
Other Study ID Numbers: H-1-2011-057
Study First Received: October 31, 2011
Last Updated: May 15, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013