Continuous Subacromial Bupivacaine

Shoulder Arthroscopy Clinical Trial

Official title:

The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377415
• Other study ID #: bupi-placebo
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: June 21, 2011
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Arthroscopy

Intervention

Drug:
• bupivacaine
bupivacaine 5 mg/ml infusion 2 ml/h 48 h

Locations

Country	Name	City	State
Finland	Turku University Hospital and University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The consumption of analgesics (oxycodone)		It was recorded on a daily basis during the first three days	No
Secondary	The intensity of pain		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	No