Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

Phase 4

Completed

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Drug: Epidural Ropivacaine, morphine; Drug: Ropivacaine, Ketorolac and Adrenaline

• Registration Number: NCT00289419
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Detailed Description

Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2006-02
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-09
• Study Completion: 2006-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients admitted consecutively to primary total hip arthroplasty due to 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
• Patients with Rheumatoid arthritis
• Patients with a daily opioid consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Epidural Ropivacaine, morphine	-
B	Ropivacaine, Ketorolac and Adrenaline	-

Primary Outcome Measures

Name	Time	Method
Consumption af analgesics	96 h

Secondary Outcome Measures

Name	Time	Method
Side effects	96 h
Mobilization level	8 h
Pain scores VAS	96 h

Trial Locations

Locations (1)

Orthopedic Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark