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

The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

258

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 156-755
        • Recruiting
        • ChungAng University
        • Contact:
          • SeongDeok Kim, M.D. & Ph.D.
          • Phone Number: +82-2-6299-2571
          • Email: ksdeok@cau.ac.kr
        • Principal Investigator:
          • Yong Chan Ha, M.D. & Ph.D.
        • Sub-Investigator:
          • Hyun Kang, M.D & PH.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • femoral neck fracture
  • partial hip replacement

Exclusion Criteria:

  • r/o infection
  • reoperation
  • mental change

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group (group C)
control group will receive no medication preoperatively and during operation
Patients in Group C wil receive none of medication preoperatively and intraoperatively
Other Names:
  • Patients in Group C wil receive none of medication
Active Comparator: 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.
periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
Other Names:
  • injection near the hip joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale 1day
Time Frame: Post Op 1 day

Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 1day.

Post Op 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption 1day
Time Frame: Post Op 1 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 1daywill be measured.
Post Op 1 day
FPB 1day
Time Frame: Post Op 1 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 1day will be measured.
Post Op 1 day
delirium rating scale at admission
Time Frame: at admission
Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion.
at admission
Visual Analogue Scale 4day
Time Frame: Post OP 4day

Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 4day.

Post OP 4day
Visual Analogue Scale 7day
Time Frame: Post Op 7day

Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

To check the severity of pain VAS will be measured at post op 7day.

Post Op 7day
Opioid consumption 4day
Time Frame: Post Op 4 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom post op 1day to post op 4 day will be measured.
Post Op 4 day
Opioid consumption 7day
Time Frame: Post Op 7 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom post op 4day to post op 7 day will be measured.
Post Op 7 day
FPB 4day
Time Frame: Post Op 4 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom post op 1day to post op 4 day will be measured.
Post Op 4 day
FPB 7day
Time Frame: Post Op 7 day
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 4day to post op 7day will be measured.
Post Op 7 day
delirium rating scale 1day
Time Frame: Post Op 1day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 1day.
Post Op 1day
delirium rating scale 4day
Time Frame: Post Op 4day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 4day.
Post Op 4day
delirium rating scale 7day
Time Frame: Post Op 7day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 7day.
Post Op 7day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yong Chan Ha, M.D. & Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Principal Investigator: Hyun Kang, M.D. & Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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