Continuous Subacromial Bupivacaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377415
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 22, 2011
Information provided by:
Turku University Hospital

June 17, 2011
June 21, 2011
June 22, 2011
January 2009
June 2010   (Final data collection date for primary outcome measure)
The consumption of analgesics (oxycodone) [ Time Frame: It was recorded on a daily basis during the first three days ]
Same as current
Complete list of historical versions of study NCT01377415 on Archive Site
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 ]
Same as current
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Continuous Subacromial Bupivacaine
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Shoulder Arthroscopy
Drug: bupivacaine
bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other Name: Bicain
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Kari Leino, Turku University Hospital
Turku University Hospital
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Turku University Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP