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

Study Overview
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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.

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

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Drug: periarticular injection of multidrug regimen
* Drug: none of medication preoperatively and intraoperatively


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: femoral neck fracture partial hip replacement Exclusion Criteria: r/o infection reoperation mental change
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group (group C)<br>control group will receive no medication preoperatively and during operation | Drug: none of medication preoperatively and intraoperatively<br>* Patients in Group C wil receive none of medication preoperatively and intraoperatively<br>* Other names: Patients in Group C wil receive none of medication;|
| Active Comparator: periarticular injecion group (group I)<br>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<br>* periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg<br>* Other names: injection near the hip joint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post Op 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post Op 1 day | 
| 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. | Post Op 1 day | 
| delirium rating scale at admission | Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion. | at admission | 
| 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. | 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. | 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. | Post Op 4 day | 
| 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. | Post Op 7 day | 
| 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. | Post Op 4 day | 
| 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. | Post Op 7 day | 
| delirium rating scale 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 | 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 | Delirium rating scale wiil be measured to check the incidence and severity of delirium at post-op 7day. | Post Op 7day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, preemptive, Postoperative, delirium