NCT01377415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

June 17, 2011

Last Update Submit

June 21, 2011

Conditions

Shoulder Arthroscopy

Keywords

arthroscopyshoulder surgerysubacromialcontinuous bupivacaine

Outcome Measures

Primary Outcomes (1)

  • The consumption of analgesics (oxycodone)

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

Secondary Outcomes (1)

  • 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

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

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

Drug: bupivacaine

saline

PLACEBO COMPARATOR

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

Drug: bupivacaine

Interventions

bupivacaineDRUG

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

Also known as: Bicain
bupivacainesaline

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subacromial impingement disease
  • scheduled for an elective arthroscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital and University of Turku

Turku, Finland

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 21, 2011

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

FI(1)