- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377415
Continuous Subacromial Bupivacaine
June 21, 2011 updated by: Turku University Hospital
The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after shoulder arthroscopy with standard surgical techniques, including rotator cuff operations.
The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.
Study Overview
Detailed Description
Shoulder surgery has become a routine outpatient procedure.
Previously shoulder surgery was associated with intense, occasionally severe postoperative pain and hence considerable use of opioids.
Also arthroscopic shoulder surgery, especially rotator cuff procedures, may cause significant pain resulting sometimes in inpatient admission.
Subacromial local anaesthetic infusion as a part of a multimodal approach is one commonly used modality to pain relief after shoulder surgery.
Nevertheless, it has been criticized recently for its poor benefits and possible adverse effects.
On the whole, the scientific evidence of the advantages of local anaesthetic infusions is inconclusive.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Turku, Finland
- Turku University Hospital and University of Turku
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subacromial impingement disease
- scheduled for an elective arthroscopic surgery
Exclusion Criteria:
- liver disease
- renal impairment
- psychiatric disorder
- alcohol abuse
- obesity (a body mass index of > 35 kg/m2)
- allergies to the drugs used in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: bupivacaine
a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h
|
bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other Names:
|
Placebo Comparator: saline
saline 9 mg/ml infusion 2 ml/h 48 h
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bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The consumption of analgesics (oxycodone)
Time Frame: It was recorded on a daily basis during the first three days
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It was recorded on a daily basis during the first three days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The intensity of pain
Time Frame: During the study the pain assessments were recorded 15 min before operation, 15 min, 6, 12 and 18 h after the beginning of the operation and on the first and third postoperative day
|
During the study the pain assessments were recorded 15 min before operation, 15 min, 6, 12 and 18 h after the beginning of the operation and on the first and third postoperative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bupi-placebo
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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