The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement

NCT ID: NCT01112436

Last Updated: 2011-06-27

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-04-30

Brief Summary

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This prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement.

Total 258 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day.

Detailed Description

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Patients in group I will receive oxycodone SR 10 mg, and celecoxib 200 mg with 10 ml of water 1 hour before surgery.

And patients in group I will receive periarticular injection of 50 ml solution which contains ropivacaine 15 mg, epinephrine 0.3 mg, cefmetazole 1000mg, ketorolac 30 mg and morphine HCL 10mg before closure of surgical wound.

Patients in group C will receive no medication.

Conditions

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Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group (group C)

control group will receive no medication preoperatively and during operation

Group Type PLACEBO_COMPARATOR

none of medication preoperatively and intraoperatively

Intervention Type DRUG

Patients in Group C wil receive none of medication preoperatively and intraoperatively

periarticular injecion group (group I)

patients in Group I will receive oral oxycodone SR 10 mg and celecoxib 200 mg 1 hour preoperatively with sips of water, and receive periarticular injection of combination of ropivacaine 15 mg, morphine 10 mg, ketorolac 30 mg epinephrine 0.3 mg and cefmetazole 1000mg during operation.

Group Type ACTIVE_COMPARATOR

periarticular injection of multidrug regimen

Intervention Type DRUG

periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg

Interventions

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periarticular injection of multidrug regimen

periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg

Intervention Type DRUG

none of medication preoperatively and intraoperatively

Patients in Group C wil receive none of medication preoperatively and intraoperatively

Intervention Type DRUG

Other Intervention Names

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injection near the hip joint Patients in Group C wil receive none of medication

Eligibility Criteria

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Inclusion Criteria

* femoral neck fracture
* partial hip replacement

Exclusion Criteria

* r/o infection
* reoperation
* mental change
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chung-Ang University Hospital

Principal Investigators

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Yong Chan Ha, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Hyun Kang, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

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ChungAng University

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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SeongDeok Kim, M.D. & Ph.D.

Role: primary

+82-2-6299-2571

Other Identifiers

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ChunaAngUH

Identifier Type: -

Identifier Source: org_study_id

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