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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01050738
Other study ID # FOUS09002
Secondary ID
Status Recruiting
Phase N/A
First received January 14, 2010
Last updated August 17, 2010
Start date January 2010
Est. completion date August 2010

Study information

Verified date August 2010
Source Spenshult Hospital
Contact Igor Dobrydnjov, MD, PhD
Phone +46-352635000
Email igor.dobrydnjov@spenshult.se
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing arthroplastic surgery of knee or hip

Exclusion Criteria:

- Sensitivity to local anesthetics

- Other reason not to use local anesthetics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Position of catheter
Position of catheter for administration of local anestesia.

Locations

Country Name City State
Sweden Spenshult Hospital Oskarström

Sponsors (1)

Lead Sponsor Collaborator
Spenshult Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Need for other postoperative analgesia. 48 hours No
Secondary Patient mobility within the first 48 hours. 48 hours No
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