Back to resultsLocal Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
Primary Purpose
Rheumatoid Arthritis, Orthopedic Surgery, Analgesia
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Position of catheter
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing arthroplastic surgery of knee or hip
Exclusion Criteria:
- Sensitivity to local anesthetics
- Other reason not to use local anesthetics
Sites / Locations
- Spenshult HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intracapsulare position
Extracapsulare position
Arm Description
Outcomes
Primary Outcome Measures
Need for other postoperative analgesia.
Secondary Outcome Measures
Patient mobility within the first 48 hours.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01050738
Brief Title
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
Official Title
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Spenshult Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Orthopedic Surgery, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracapsulare position
Arm Type
Active Comparator
Arm Title
Extracapsulare position
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Position of catheter
Intervention Description
Position of catheter for administration of local anestesia.
Primary Outcome Measure Information:
Title
Need for other postoperative analgesia.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Patient mobility within the first 48 hours.
Time Frame
48 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing arthroplastic surgery of knee or hip
Exclusion Criteria:
Sensitivity to local anesthetics
Other reason not to use local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Dobrydnjov, MD, PhD
Phone
+46-352635000
Email
igor.dobrydnjov@spenshult.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Bergman, MD, PhD
Organizational Affiliation
R&D-center Spenshult
Official's Role
Study Chair
Facility Information:
Facility Name
Spenshult Hospital
City
Oskarström
ZIP/Postal Code
SE-31392
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Dobrydnjov, MD, PhD
Phone
+46-352635000
Email
igor.dobrydnjov@spenshult.se
12. IPD Sharing Statement
Learn more about this trial
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
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