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Selective Block of the Axillary Nerve in Postoperative Pain Management

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ClinicalTrials.gov Identifier: NCT01463865
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Pain, Postoperative Drug: ropivacaine Drug: Sodium chloride

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
Study Start Date : November 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Naropin


Outcome Measures

Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 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 :
  1. Visual analogue scale (VAS) score [ Time Frame: 0-12 hours and 12-24 hours postoperatively ]
    Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.

  2. Total morphine consumption [ Time Frame: 0-24 hours postoperatively ]
    The total amount of morphine administered during the first 24 hours postoperatively

  3. Postoperative nausea and vomiting (PONV) [ Time Frame: 0-4, 0-12 and 12-24 hours postoperatively ]
    Postoperative nausea evaluated on a 1-3 scale with and without vomiting

  4. Escape block [ Time Frame: 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.

  5. Bolus morphine 5 mg iv [ Time Frame: 0-4 hours postoperatively ]
    Number of morphine boli administered during the first 4 hours postoperatively


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463865


Locations
Denmark
Aleris-Hamlet Hospital
Frederiksberg, Denmark
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
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

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