Selective Block of the Axillary Nerve in Postoperative Pain Management

NCT ID: NCT01463865

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Sodium chloride

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

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

ropivacaine

Naropin

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

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

Interventions

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ropivacaine

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

Intervention Type DRUG

Sodium chloride

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

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kai Henrik Wiborg Lange

Head of research, Associate professor, phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aleris-Hamlet Hospital

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 21827442 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32005160 (View on PubMed)

Other Identifiers

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H-1-2011-057

Identifier Type: -

Identifier Source: org_study_id

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