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

Femoral Neck Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112436
• Other study ID #: ChunaAngUH
• Status: Recruiting
• Phase: Phase 4
• First received: April 22, 2010
• Last updated: June 23, 2011
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2010
• Source: Chung-Ang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• femoral neck fracture

• partial hip replacement

Exclusion Criteria:

• r/o infection

• reoperation

• mental change

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures

Intervention

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
• none of medication preoperatively and intraoperatively
Patients in Group C wil receive none of medication preoperatively and intraoperatively

Locations

Country	Name	City	State
Korea, Republic of	ChungAng University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	delirium rating scale at admission	Delirium rating scale wiil be measured to compare with the post op delerium scale at admisssion.	at admission	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No