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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603083
• Other study ID #: EudraCT number 2007-003890-20
• Secondary ID: S-20070066
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2008
• Last updated: December 8, 2011
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: December 2011
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Orthopaedic Department	Vejle
Denmark	Ortopaedic Department, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score		24 hours	No
Primary	Opioid Consumption		24 hours	No
Secondary	Pain score		7 days	No
Secondary	Opioid consumption		3 days	No
Secondary	Postoperative Nausea and Vomiting (PONV)		3 days	No
Secondary	Fatigue		3 days	No
Secondary	Physical function		2 month	No