Femoral Neck FracturePhase 4NCT01112436
The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement
A Phase 4 study testing periarticular injection of multidrug regimen and none of medication preoperatively and intraoperatively in people with Femoral Neck Fracture, run by Chung-Ang University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- periarticular injection of multidrug regimen and none of medication preoperatively and intraoperatively
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- femoral neck fracture
- partial hip replacement
Who cannot join
- r/o infection
- reoperation
- mental change
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
ChungAng University
Seoul, 156-755
SeongDeok Kim, M.D. & Ph.D., +82-2-6299-2571, ksdeok@cau.ac.kr
Yong Chan Ha, M.D. & Ph.D.
About this study
Official title: The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.
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.
Read more
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.
Read the 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.
- Conditions
- Femoral Neck Fracture
- Being tested
- periarticular injection of multidrug regimen, none of medication preoperatively and intraoperatively
- Keywords
- Pain, preemptive, Postoperative, delirium
- Medical subject headings
- Femoral Neck Fractures, Pain, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periarticular injection of multidrug regimenDrug
Also called injection near the hip joint
periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
none of medication preoperatively and intraoperativelyDrug
Also called Patients in Group C wil receive none of medication
Patients in Group C wil receive none of medication preoperatively and intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| control group (group C) | Placebo comparator | control group will receive no medication preoperatively and during operation Receives: Drug: none of medication preoperatively and intraoperatively |
| periarticular injecion group (group I) | Active comparator | 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. Receives: Drug: periarticular injection of multidrug regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post Op 1 day
Secondary outcomes (12)
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: Post Op 7day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yong Chan Ha, M.D. & Ph.D., Study director, Chung-Ang University HospitalHyun Kang, M.D. & Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112436
- Sponsor's protocol ID
- ChunaAngUH
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT01112436
- Acronym / sponsor ID
- ChunaAngUH
- Conditions
- Femoral Neck Fracture
- Keywords
- Pain, preemptive, Postoperative, delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (group C) | Placebo comparator | Drug: none of medication preoperatively and intraoperativelycontrol group will receive no medication preoperatively and during operation |
| periarticular injecion group (group I) | Active comparator | Drug: periarticular injection of multidrug regimenpatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- femoral neck fracture
- partial hip replacement
Key exclusion criteria (3 listed)
- r/o infection
- reoperation
- mental change
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periarticular injection of multidrug regimenAlso: injection near the hip jointperiarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg | Drug | periarticular injecion group (group I) |
| none of medication preoperatively and intraoperativelyAlso: Patients in Group C wil receive none of medicationPatients in Group C wil receive none of medication preoperatively and intraoperatively | Drug | control group (group C) |
Primary outcome
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.
12 secondary outcomes
Opioid consumption 1day
Time frame: Post Op 1 day
FPB 1day
Time frame: Post Op 1 day
delirium rating scale at admission
Time frame: at admission
Visual Analogue Scale 4day
Time frame: Post OP 4day
Visual Analogue Scale 7day
Time frame: Post Op 7day
Opioid consumption 4day
Time frame: Post Op 4 day
Opioid consumption 7day
Time frame: Post Op 7 day
FPB 4day
Time frame: Post Op 4 day
FPB 7day
Time frame: Post Op 7 day
delirium rating scale 1day
Time frame: Post Op 1day
delirium rating scale 4day
Time frame: Post Op 4day
delirium rating scale 7day
Time frame: Post Op 7day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Chan Ha, M.D. & Ph.D. study director
Chung-Ang University Hospital
Hyun Kang, M.D. & Ph.D. principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing periarticular injection of multidrug regimen and none of medication preoperatively and intraoperatively in people with Femoral Neck Fracture, run by Chung-Ang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale 1day (time frame: Post Op 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.