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

Vejle Hospital

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: Ropivacaine, Ketorolac and Adrenalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00603083

S-20070066

EudraCT number 2007-003890-20

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine, Ketorolac and Adrenalin

B

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo