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Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

NCT ID: NCT00289419

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Detailed Description

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Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Conditions

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Arthroplasty, Replacement, Hip

Keywords

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Arthroplasty, Replacement, Hip Anesthetics, Local Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Epidural Ropivacaine, morphine

Intervention Type DRUG

Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml

B

Group Type EXPERIMENTAL

Ropivacaine, Ketorolac and Adrenaline

Intervention Type DRUG

Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml

Interventions

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Epidural Ropivacaine, morphine

Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml

Intervention Type DRUG

Ropivacaine, Ketorolac and Adrenaline

Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

Exclusion Criteria

* Patients unable to provide informed consent
* Patients with contraindications for spinal anesthesia
* Patients with known hypersensitivity towards the used drugs
* Patients with severe chronic neurogenic pain
* Patients with Rheumatoid arthritis
* Patients with a daily opioid consumption
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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University of Aarhus

Principal Investigators

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Kjeld Søballe, Professor

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark

Locations

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Orthopedic Center, Aarhus University Hospital

Aarhus, Aarhus, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20040199

Identifier Type: -

Identifier Source: org_study_id