Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

Official Title: “Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Epidural Ropivacaine, morphine
  • Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml
• Drug: Ropivacaine, Ketorolac and Adrenaline
  • Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Experimental: B

Primary Measures

• Consumption af analgesics
  • Time Frame: 96 h
    Safety Issue?: No

Secondary Measures

• Side effects
  • Time Frame: 96 h
    Safety Issue?: Yes
• Mobilization level
  • Time Frame: 8 h
    Safety Issue?: No
• Pain scores VAS
  • Time Frame: 96 h
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Aarhus Other

Overall Clinical Trial Officials and Contacts

Kjeld Søballe, Professor Principal Investigator Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289419

Study ID Number: 20040199

ClinicalTrials.gov Identifier: NCT00289419

Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics