Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study - Full Text View

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 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:

MedlinePlus related topics: Hip Replacement

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Consumption af analgesics [ Time Frame: 96 h ]

Secondary Outcome Measures:

Side effects [ Time Frame: 96 h ]
Mobilization level [ Time Frame: 8 h ]
Pain scores VAS [ Time Frame: 96 h ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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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


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

Keywords provided by University of Aarhus:


Arthroplasty, Replacement, Hip Anesthetics, Local Pain, Postoperative

Additional relevant MeSH terms:


Morphine Ketorolac Ketorolac Tromethamine Ropivacaine Epinephrine Racepinephrine Epinephryl borate Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local	Anesthetics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents

ClinicalTrials.gov processed this record on May 25, 2017