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

Primary Purpose

Femoral Neck Fracture

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
periarticular injection of multidrug regimen
none of medication preoperatively and intraoperatively
Sponsored by
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Pain, preemptive, Postoperative, delirium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • femoral neck fracture
  • partial hip replacement

Exclusion Criteria:

  • r/o infection
  • reoperation
  • mental change

Sites / Locations

  • ChungAng UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group (group C)

periarticular injecion group (group I)

Arm Description

control group will receive no medication preoperatively and during operation

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.

Outcomes

Primary Outcome Measures

Visual analogue scale 1day
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.

Secondary Outcome Measures

Opioid consumption 1day
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.
FPB 1day
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.
delirium rating scale at admission
Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion.
Visual Analogue Scale 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.
Visual Analogue Scale 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.
Opioid consumption 4day
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.
Opioid consumption 7day
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.
FPB 4day
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.
FPB 7day
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.
delirium rating scale 1day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 1day.
delirium rating scale 4day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 4day.
delirium rating scale 7day
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 7day.

Full Information

First Posted
April 22, 2010
Last Updated
June 23, 2011
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01112436
Brief Title
The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement
Official Title
The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Pain, preemptive, Postoperative, delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group (group C)
Arm Type
Placebo Comparator
Arm Description
control group will receive no medication preoperatively and during operation
Arm Title
periarticular injecion group (group I)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
periarticular injection of multidrug regimen
Other Intervention Name(s)
injection near the hip joint
Intervention Description
periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
Intervention Type
Drug
Intervention Name(s)
none of medication preoperatively and intraoperatively
Other Intervention Name(s)
Patients in Group C wil receive none of medication
Intervention Description
Patients in Group C wil receive none of medication preoperatively and intraoperatively
Primary Outcome Measure Information:
Title
Visual analogue scale 1day
Description
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.
Time Frame
Post Op 1 day
Secondary Outcome Measure Information:
Title
Opioid consumption 1day
Description
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.
Time Frame
Post Op 1 day
Title
FPB 1day
Description
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.
Time Frame
Post Op 1 day
Title
delirium rating scale at admission
Description
Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion.
Time Frame
at admission
Title
Visual Analogue Scale 4day
Description
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.
Time Frame
Post OP 4day
Title
Visual Analogue Scale 7day
Description
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.
Time Frame
Post Op 7day
Title
Opioid consumption 4day
Description
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.
Time Frame
Post Op 4 day
Title
Opioid consumption 7day
Description
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.
Time Frame
Post Op 7 day
Title
FPB 4day
Description
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.
Time Frame
Post Op 4 day
Title
FPB 7day
Description
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.
Time Frame
Post Op 7 day
Title
delirium rating scale 1day
Description
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 1day.
Time Frame
Post Op 1day
Title
delirium rating scale 4day
Description
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 4day.
Time Frame
Post Op 4day
Title
delirium rating scale 7day
Description
Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 7day.
Time Frame
Post Op 7day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: femoral neck fracture partial hip replacement Exclusion Criteria: r/o infection reoperation mental change
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Chan Ha, M.D. & Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyun Kang, M.D. & Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChungAng University
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeongDeok Kim, M.D. & Ph.D.
Phone
+82-2-6299-2571
Email
ksdeok@cau.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Chan Ha, M.D. & Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyun Kang, M.D & PH.D

12. IPD Sharing Statement

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

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