Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289419
• Other study ID #: 20040199
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2006
• Last updated: May 6, 2008
• Start date: February 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2008
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Orthopedic Center, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption af analgesics		96 h	No
Secondary	Side effects		96 h	Yes
Secondary	Mobilization level		8 h	No
Secondary	Pain scores VAS		96 h	No