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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine, Ketorolac and Adrenalin; Drug: Placebo

• Registration Number: NCT00603083
• Lead Sponsor: Vejle Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-26
• Study First Posted: 2008-01-28
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Ropivacaine, Ketorolac and Adrenalin	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.
B	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Pain score	24 hours
Opioid Consumption	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Orthopaedic Department; 🇩🇰 Vejle, Denmark

Ortopaedic Department, Vejle Hospital; 🇩🇰 Vejle, Denmark