The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Femoral Neck Fracture |
Drug: periarticular injection of multidrug regimen Drug: none of medication preoperatively and intraoperatively |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study. |
- Visual analogue scale 1day [ Time Frame: Post Op 1 day ] [ Designated as safety issue: No ]
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.
- Opioid consumption 1day [ Time Frame: Post Op 1 day ] [ Designated as safety issue: No ]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 [ Time Frame: Post Op 1 day ] [ Designated as safety issue: No ]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 [ Time Frame: at admission ] [ Designated as safety issue: No ]Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion.
- Visual Analogue Scale 4day [ Time Frame: Post OP 4day ] [ Designated as safety issue: No ]
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 [ Time Frame: Post Op 7day ] [ Designated as safety issue: No ]
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 [ Time Frame: Post Op 4 day ] [ Designated as safety issue: No ]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 [ Time Frame: Post Op 7 day ] [ Designated as safety issue: No ]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 [ Time Frame: Post Op 4 day ] [ Designated as safety issue: No ]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 [ Time Frame: Post Op 7 day ] [ Designated as safety issue: No ]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 [ Time Frame: Post Op 1day ] [ Designated as safety issue: No ]Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 1day.
- delirium rating scale 4day [ Time Frame: Post Op 4day ] [ Designated as safety issue: No ]Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 4day.
- delirium rating scale 7day [ Time Frame: Post Op 7day ] [ Designated as safety issue: No ]Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 7day.
| Estimated Enrollment: | 258 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: control group (group C)
control group will receive no medication preoperatively and during operation
|
Drug: none of medication preoperatively and intraoperatively
Patients in Group C wil receive none of medication preoperatively and intraoperatively
Other Name: 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.
|
Drug: periarticular injection of multidrug regimen
periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
Other Name: injection near the hip joint
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- femoral neck fracture
- partial hip replacement
Exclusion Criteria:
- r/o infection
- reoperation
- mental change
Contacts and Locations| Korea, Republic of | |
| ChungAng University | Recruiting |
| Seoul, Korea, Republic of, 156-755 | |
| Contact: SeongDeok Kim, M.D. & Ph.D. +82-2-6299-2571 ksdeok@cau.ac.kr | |
| Principal Investigator: Yong Chan Ha, M.D. & Ph.D. | |
| Sub-Investigator: Hyun Kang, M.D & PH.D | |
| Study Director: | Yong Chan Ha, M.D. & Ph.D. | Chungang University Hospital |
| Principal Investigator: | Hyun Kang, M.D. & Ph.D. | Chungang University Hospital |
More Information
No publications provided
| Responsible Party: | Yong Chan Ha, Chung-Ang University Hospital |
| ClinicalTrials.gov Identifier: | NCT01112436 History of Changes |
| Other Study ID Numbers: | ChunaAngUH |
| Study First Received: | April 22, 2010 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Chung-Ang University Hospital:
|
Pain preemptive Postoperative delirium |
Additional relevant MeSH terms:
|
Femoral Neck Fractures Hip Fractures Femoral Fractures |
Fractures, Bone Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on June 18, 2013