Continuous Subacromial Bupivacaine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Arthroscopy

Intervention / Treatment
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* Drug: bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h | Drug: bupivacaine<br>* bupivacaine 5 mg/ml infusion 2 ml/h 48 h<br>* Other names: Bicain;|
| Placebo Comparator: saline<br>saline 9 mg/ml infusion 2 ml/h 48 h | Drug: bupivacaine<br>* bupivacaine 5 mg/ml infusion 2 ml/h 48 h<br>* Other names: Bicain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The consumption of analgesics (oxycodone) |  | It was recorded on a daily basis during the first three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopy, shoulder surgery, subacromial, continuous bupivacaine