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Selective Block of the Axillary Nerve in Postoperative Pain Management

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463865
Enrollment
60
Registered
2011-11-02
Start date
2011-11-30
Completion date
2013-08-31
Last updated
2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGropivacaine

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

DRUGSodium chloride

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

Sponsors

Hillerod Hospital, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumption0-4 hours postoperativelyPatients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.

Secondary

MeasureTime frameDescription
Visual analogue scale (VAS) score0-12 hours and 12-24 hours postoperativelyPostoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
Total morphine consumption0-24 hours postoperativelyThe total amount of morphine administered during the first 24 hours postoperatively
Postoperative nausea and vomiting (PONV)0-4, 0-12 and 12-24 hours postoperativelyPostoperative nausea evaluated on a 1-3 scale with and without vomiting
Escape block0-4 hours postoperativelyThe 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 iv0-4 hours postoperativelyNumber of morphine boli administered during the first 4 hours postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026