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Selective Block of the Axillary Nerve in Postoperative Pain Management

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ropivacaine
Sodium chloride
Sponsored by
Hillerod Hospital, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aleris-Hamlet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

ropivacaine

Arm Description

Sodium chloride

Naropin

Outcomes

Primary Outcome Measures

Morphine consumption
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
Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
Total morphine consumption
The total amount of morphine administered during the first 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Postoperative nausea evaluated on a 1-3 scale with and without vomiting
Escape block
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
Number of morphine boli administered during the first 4 hours postoperatively

Full Information

First Posted
October 31, 2011
Last Updated
March 19, 2015
Sponsor
Hillerod Hospital, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01463865
Brief Title
Selective Block of the Axillary Nerve in Postoperative Pain Management
Official Title
Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillerod Hospital, Denmark

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride
Arm Title
ropivacaine
Arm Type
Active Comparator
Arm Description
Naropin
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.
Time Frame
0-4 hours postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) score
Description
Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
Time Frame
0-12 hours and 12-24 hours postoperatively
Title
Total morphine consumption
Description
The total amount of morphine administered during the first 24 hours postoperatively
Time Frame
0-24 hours postoperatively
Title
Postoperative nausea and vomiting (PONV)
Description
Postoperative nausea evaluated on a 1-3 scale with and without vomiting
Time Frame
0-4, 0-12 and 12-24 hours postoperatively
Title
Escape block
Description
The use of an escape block (interscalene brachial plexus block) in patients with pain breakthrough despite IV morphine 0-4 hours postoperatively.
Time Frame
0-4 hours postoperatively
Title
Bolus morphine 5 mg iv
Description
Number of morphine boli administered during the first 4 hours postoperatively
Time Frame
0-4 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aleris-Hamlet Hospital
City
Frederiksberg
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21827442
Citation
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.
Results Reference
background
PubMed Identifier
32005160
Citation
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.
Results Reference
derived

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Selective Block of the Axillary Nerve in Postoperative Pain Management

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