Continuous Subacromial Bupivacaine

Turku University Hospital (TYKS)

Status: Completed

Conditions: Shoulder Arthroscopy

Treatments: Drug: bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01377415

bupi-placebo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: bupivacaine

saline

Placebo Comparator group

Description:

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

Treatment:

Drug: bupivacaine