Continuous Subacromial Bupivacaine

Not Applicable

Completed

• Conditions: Shoulder Arthroscopy
• Interventions: Drug: bupivacaine

• Registration Number: NCT01377415
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-06
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	bupivacaine	saline 9 mg/ml infusion 2 ml/h 48 h
bupivacaine	bupivacaine	a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h

Primary Outcome Measures

Name	Time	Method
The consumption of analgesics (oxycodone)	It was recorded on a daily basis during the first three days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Turku University Hospital and University of Turku; 🇫🇮 Turku, Finland