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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Chung-Ang University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01112436
First received: April 22, 2010
Last updated: June 23, 2011
Last verified: April 2010
  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.

Resource links provided by NLM:


Further study details as provided by Chung-Ang University Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • femoral neck fracture
  • partial hip replacement

Exclusion Criteria:

  • r/o infection
  • reoperation
  • mental change
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112436

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         
Sponsors and Collaborators
Chung-Ang University Hospital
Investigators
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 August 01, 2014