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Continuous Subacromial Bupivacaine

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01377415
Enrollment
90
Registered
2011-06-21
Start date
2009-01-31
Completion date
2010-06-30
Last updated
2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroscopy

Keywords

arthroscopy, shoulder surgery, subacromial, continuous bupivacaine

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.

Interventions

DRUGbupivacaine

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

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The consumption of analgesics (oxycodone)It was recorded on a daily basis during the first three days

Secondary

MeasureTime frame
The intensity of painDuring 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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026