- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112436
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
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- femoral neck fracture
- partial hip replacement
Exclusion Criteria:
- r/o infection
- reoperation
- mental change
Study Plan
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:
|
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:
|
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
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChunaAngUH
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