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NCT Number: NCT01377415

Continuous Subacromial Bupivacaine

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.

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Key information

Conditions

Shoulder Arthroscopy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital and University of Turku

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: Bicain

Primary outcomes

  1. The consumption of analgesics (oxycodone)

    Time frame: It was recorded on a daily basis during the first three days

Secondary outcomes

  1. The intensity of pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 21, 2011
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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