Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia - Full Text View

Sponsored by:	Vejle Hospital
Information provided by:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00603083

Purpose

The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Ropivacaine, Ketorolac and Adrenalin Drug: Placebo	Phase IV

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Sodium chloride Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Ketorolac Ketorolac tromethamine Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-Blinded Placebo-Controlled Study to Assess the Effect of Local Analgesia

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Opioid Consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain score [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Opioid consumption [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Postoperative Nausea and Vomiting (PONV) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Fatigue [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Physical function [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.	Drug: Ropivacaine, Ketorolac and Adrenalin The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
B: Placebo Comparator This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.	Drug: Placebo This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.

Eligibility

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

Criteria

Inclusion Criteria:

Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
Willingness and possibility to follow the instructions of the study
18 years or older
written informed consent and authority after it has been read and understood.

Exclusion Criteria:

Operation with anterior approach or using navigation
Do not understand or speech danish
Can not use the pain-score Numerical Rating Scale (NRS)
Special indications for Total Hip Replacement
Anaesthetized in general anaesthesia where a tube is demanded
Daily use of strong opioids, based on the investigators assessment
Fertile women
ASA-score: 3 and 4
Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
Following illness:
Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
Haemorrhagic diathesis
Coagulation disorder
Severe thrombocytopenia
Severe heart insufficiency
Severe risk of postoperative bleeding or delayed haemostatic
Myocardium hypertrophy or ischaemic heart disease
Hypertension
Hypovolemics
Anhydration
angiooedema
Asthma
Bronchospasm
Severe liver insufficiency
Rhinostenosis because of polyostotic
Narrow-angled glaucoma
Phaeochromocytoma
Low plasm-potassium
Thyreotoxicosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603083

Locations

Denmark
Orthopaedic Department
Vejle, Denmark, 7100
Ortopaedic Department, Vejle Hospital
Vejle, Denmark, 7100

Sponsors and Collaborators

Vejle Hospital

Investigators

Principal Investigator:

Per Kjaersgaard-Andersen, MD

Ortopaedic Department, Vejle Hospital, Denmark

More Information

Responsible Party:	Orthopaedic Department, Vejle Hospital ( Per Kjaersgaard-Andersen MD )
Study ID Numbers:	EudraCT number 2007-003890-20, S-20070066
Study First Received:	January 2, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00603083
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Ministry of the Interior and Health

Keywords provided by Vejle Hospital:

Hip Arthroplasty
Treatment Outcome
Local Anesthesia

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Ropivacaine
Ketorolac

Pain
Epinephrine
Ketorolac Tromethamine
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Anesthetics
Enzyme Inhibitors
Anesthetics, Local
Pharmacologic Actions

Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009