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

Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine, Ketorolac and Adrenalin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; 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.; Other Names: Naropin; Toradol
Placebo Comparator: B; 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.; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain score	24 hours
Opioid Consumption	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain score	7 days
Opioid consumption	3 days
Postoperative Nausea and Vomiting (PONV)	3 days
Fatigue	3 days
Physical function	2 month

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Per Kjaersgaard-Andersen, MD, Ortopaedic Department, Vejle Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 26, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): December 9, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Hip Arthroplasty; Treatment Outcome; Local Anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ketorolac; Ropivacaine
• Other Study ID Numbers: EudraCT number 2007-003890-20; S-20070066