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Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00289419
First received: February 8, 2006
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Arthroplasty, Replacement, Hip
Drug: Epidural Ropivacaine, morphine
Drug: Ropivacaine, Ketorolac and Adrenaline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Consumption af analgesics [ Time Frame: 96 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 96 h ] [ Designated as safety issue: Yes ]
  • Mobilization level [ Time Frame: 8 h ] [ Designated as safety issue: No ]
  • Pain scores VAS [ Time Frame: 96 h ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2005
Study Completion Date: March 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 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
Experimental: B 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289419

Locations
Denmark
Orthopedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kjeld Søballe, Professor Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Professor Kjeld Soballe, University of Aarhus
ClinicalTrials.gov Identifier: NCT00289419     History of Changes
Other Study ID Numbers: 20040199
Study First Received: February 8, 2006
Last Updated: May 6, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Arthroplasty, Replacement, Hip
Anesthetics, Local
Pain, Postoperative

Additional relevant MeSH terms:
Ketorolac
Ropivacaine
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014