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

• Sponsor: Spenshult Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01050738
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 10.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Orthopedic Surgery; Analgesia	Procedure: Position of catheter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2010
• Anticipated Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Need for other postoperative analgesia. [48 hours]

Secondary Outcome Measures

1. Patient mobility within the first 48 hours. [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Spenshult Hospital	Oskarström		Sweden	SE-31392

Sponsors and Collaborators

• Spenshult Hospital

Investigators

• Study Chair: Stefan Bergman, MD, PhD, R&D-center Spenshult

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01050738
• Other Study ID Numbers: FOUS09002
• First Posted: Jan 15, 2010
• Last Update Posted: Aug 18, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Rheumatic Diseases; Collagen Diseases

Study Results

No Results Posted as of Aug 18, 2010