Clinical trial NCT01112436: The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement
Official title: The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Femoral Neck Fracture
Keywords: Pain
preemptive
Postoperative
delirium
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* femoral neck fracture
* partial hip replacement

Exclusion Criteria:

* r/o infection
* reoperation
* mental change

Primary outcomes:
measure: Visual analogue scale 1day
timeFrame: Post Op 1 day
Secondary outcomes:
measure: Opioid consumption 1day
timeFrame: Post Op 1 day
measure: FPB 1day
timeFrame: Post Op 1 day
measure: delirium rating scale at admission
timeFrame: at admission
measure: Visual Analogue Scale 4day
timeFrame: Post OP 4day
measure: Visual Analogue Scale 7day
timeFrame: Post Op 7day
measure: Opioid consumption 4day
timeFrame: Post Op 4 day
measure: Opioid consumption 7day
timeFrame: Post Op 7 day
measure: FPB 4day
timeFrame: Post Op 4 day
measure: FPB 7day
timeFrame: Post Op 7 day
measure: delirium rating scale 1day
timeFrame: Post Op 1day
measure: delirium rating scale 4day
timeFrame: Post Op 4day
measure: delirium rating scale 7day
timeFrame: Post Op 7day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChungAng University
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Yong Chan Ha, M.D. & Ph.D.
role: STUDY_DIRECTOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: