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Continuous Subacromial Bupivacaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377415
First Posted: June 21, 2011
Last Update Posted: June 22, 2011
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.
Information provided by:
Turku University Hospital
  Purpose
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.

Condition Intervention
Shoulder Arthroscopy Drug: bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The consumption of analgesics (oxycodone) [ Time Frame: It was recorded on a daily basis during the first three days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bupivacaine
a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h
Drug: bupivacaine
bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other Name: Bicain
Placebo Comparator: saline
saline 9 mg/ml infusion 2 ml/h 48 h
Drug: bupivacaine
bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other Name: Bicain

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.
  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377415


Locations
Finland
Turku University Hospital and University of Turku
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
  More Information

Responsible Party: Kari Leino, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01377415     History of Changes
Other Study ID Numbers: bupi-placebo
First Submitted: June 17, 2011
First Posted: June 21, 2011
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Turku University Hospital:
arthroscopy
shoulder surgery
subacromial
continuous bupivacaine

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents