Continuous Subacromial Bupivacaine

NCT ID: NCT01377415

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Shoulder Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

bupivacaine

a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

bupivacaine 5 mg/ml infusion 2 ml/h 48 h

saline

saline 9 mg/ml infusion 2 ml/h 48 h

Group Type: PLACEBO_COMPARATOR

bupivacaine

Intervention Type: DRUG

bupivacaine 5 mg/ml infusion 2 ml/h 48 h

Interventions

bupivacaine

bupivacaine 5 mg/ml infusion 2 ml/h 48 h

Intervention Type: DRUG

Other Intervention Names

Bicain

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Turku University Hospital

Locations

Turku University Hospital and University of Turku

Turku, , Finland

Countries

Finland

Other Identifiers

bupi-placebo

Identifier Type: -

Identifier Source: org_study_id