Continuous Subacromial Bupivacaine

This study has been completed.

Sponsor:

Information provided by:

Turku University Hospital

ClinicalTrials.gov Identifier:

NCT01377415

First received: June 17, 2011

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 17, 2011
Last Updated Date	June 21, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 20, 2011)	The consumption of analgesics (oxycodone) [ Time Frame: It was recorded on a daily basis during the first three days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01377415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 20, 2011)	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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Continuous Subacromial Bupivacaine
Official Title ^ICMJE	The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Shoulder Arthroscopy
Intervention ^ICMJE	Drug: bupivacaine bupivacaine 5 mg/ml infusion 2 ml/h 48 h Other Name: Bicain
Study Arm (s)	Active Comparator: bupivacaine a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h Intervention: Drug: bupivacaine Placebo Comparator: saline saline 9 mg/ml infusion 2 ml/h 48 h Intervention: Drug: bupivacaine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	90
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01377415
Other Study ID Numbers ^ICMJE	bupi-placebo
Has Data Monitoring Committee	Not Provided
Responsible Party	Kari Leino, Turku University Hospital
Study Sponsor ^ICMJE	Turku University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Turku University Hospital
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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