Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Spenshult Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spenshult Hospital
ClinicalTrials.gov Identifier:
NCT01050738
First received: January 14, 2010
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Orthopedic Surgery
Analgesia
Procedure: Position of catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

Resource links provided by NLM:


Further study details as provided by Spenshult Hospital:

Primary Outcome Measures:
  • Need for other postoperative analgesia. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient mobility within the first 48 hours. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intracapsulare position Procedure: Position of catheter
Position of catheter for administration of local anestesia.
Active Comparator: Extracapsulare position Procedure: Position of catheter
Position of catheter for administration of local anestesia.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing arthroplastic surgery of knee or hip

Exclusion Criteria:

  • Sensitivity to local anesthetics
  • Other reason not to use local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050738

Contacts
Contact: Igor Dobrydnjov, MD, PhD +46-352635000 igor.dobrydnjov@spenshult.se

Locations
Sweden
Spenshult Hospital Recruiting
Oskarström, Sweden, SE-31392
Contact: Igor Dobrydnjov, MD, PhD    +46-352635000    igor.dobrydnjov@spenshult.se   
Sponsors and Collaborators
Spenshult Hospital
Investigators
Study Chair: Stefan Bergman, MD, PhD R&D-center Spenshult
  More Information

No publications provided

Responsible Party: Stefan Bergman/MD, PhD, Research Director, R&D-center Spenshult
ClinicalTrials.gov Identifier: NCT01050738     History of Changes
Other Study ID Numbers: FOUS09002
Study First Received: January 14, 2010
Last Updated: August 17, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014