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NCT Number: NCT00289419

Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopedic Center, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural Ropivacaine, morphine

Drug

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

Drug

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

Primary outcomes

  1. Consumption af analgesics

    Time frame: 96 h

Secondary outcomes

  1. Side effects

    Time frame: 96 h

  2. Mobilization level

    Time frame: 8 h

  3. Pain scores VAS

    Time frame: 96 h

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 9, 2006
Registry last updated
May 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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