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

June 17, 2011
June 21, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01377415 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01377415
bupi-placebo
Not Provided
Kari Leino, Turku University Hospital
Turku University Hospital
Not Provided
Not Provided
Turku University Hospital
June 2011

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