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Completed

NCT Number: NCT01463865

Selective Block of the Axillary Nerve in Postoperative Pain Management

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aleris-Hamlet Hospital

Frederiksberg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Other names: Naropin

Sodium Chloride

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2011
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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