Skip to main content
Clinical Trials/NCT01112436
NCT01112436
Unknown
Phase 4

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

Chung-Ang University Hosptial, Chung-Ang University College of Medicine1 site in 1 country258 target enrollmentMay 2010

Overview

Phase
Phase 4
Intervention
none of medication preoperatively and intraoperatively
Conditions
Femoral Neck Fracture
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Enrollment
258
Locations
1
Primary Endpoint
Visual analogue scale 1day
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
April 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • femoral neck fracture
  • partial hip replacement

Exclusion Criteria

  • r/o infection
  • reoperation
  • mental change

Arms & Interventions

control group (group C)

control group will receive no medication preoperatively and during operation

Intervention: none of medication preoperatively and intraoperatively

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.

Intervention: periarticular injection of multidrug regimen

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Opioid consumption 1day(Post Op 1 day)
  • FPB 1day(Post Op 1 day)
  • delirium rating scale at admission(at admission)
  • Visual Analogue Scale 4day(Post OP 4day)
  • Visual Analogue Scale 7day(Post Op 7day)
  • Opioid consumption 4day(Post Op 4 day)
  • Opioid consumption 7day(Post Op 7 day)
  • FPB 4day(Post Op 4 day)
  • FPB 7day(Post Op 7 day)
  • delirium rating scale 1day(Post Op 1day)
  • delirium rating scale 4day(Post Op 4day)
  • delirium rating scale 7day(Post Op 7day)

Study Sites (1)

Loading locations...

Similar Trials