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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377415

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

No publications provided

Responsible Party: Kari Leino, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01377415     History of Changes
Other Study ID Numbers: bupi-placebo
Study First Received: June 17, 2011
Last Updated: June 21, 2011
Health Authority: Finland: Finnish Medicines Agency

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014