Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269529
• Other study ID #: 20050003
• Status: Completed
• Phase: N/A
• First received: December 22, 2005
• Last updated: October 12, 2006
• Start date: February 2005
• Est. completion date: March 2006

Study information

• Verified date: October 2006
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.

Description:

Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients planned for primary total knee arthroplasty due to primary arthrosis

Exclusion Criteria:

• Patients unable to provide informed consent

• patients with contraindications for spinal anesthesia

• patients with known hypersensitivity towards the used drugs

• patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated

• patients who have undergone major bone surgery in the knee to be operated

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• femoral nerve block

• knee infiltration and injection via catheter

Locations

Country	Name	City	State
Denmark	Aarhus Hospital, Tage Hansens Gade	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain, by numeric rating scale
Primary	pain, by consumption of analgesics
Primary	side effects
Primary	return of function