NCT01050738

Brief Summary

Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 18, 2010

Status Verified

August 1, 2010

Enrollment Period

7 months

First QC Date

January 14, 2010

Last Update Submit

August 17, 2010

Conditions

Rheumatoid ArthritisOrthopedic SurgeryAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Need for other postoperative analgesia.

    48 hours

Secondary Outcomes (1)

  • Patient mobility within the first 48 hours.

    48 hours

Study Arms (2)

Intracapsulare position

ACTIVE COMPARATOR
Procedure: Position of catheter

Extracapsulare position

ACTIVE COMPARATOR
Procedure: Position of catheter

Interventions

Position of catheterPROCEDURE

Position of catheter for administration of local anestesia.

Extracapsulare positionIntracapsulare position

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing arthroplastic surgery of knee or hip

You may not qualify if:

  • Sensitivity to local anesthetics
  • Other reason not to use local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spenshult Hospital

Oskarström, SE-31392, Sweden

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidAgnosia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Bergman, MD, PhD

    R&D-center Spenshult

    STUDY CHAIR

Central Study Contacts

Igor Dobrydnjov, MD, PhD

CONTACT

+46-352635000igor.dobrydnjov@spenshult.se

Study Design

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

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 18, 2010

Record last verified: 2010-08

Locations

SE(1)