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

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

Status and phase: Unknown; Phase 4

Conditions: Femoral Neck Fracture

Treatments: Drug: none of medication preoperatively and intraoperatively; Drug: periarticular injection of multidrug regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01112436

ChunaAngUH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• femoral neck fracture
• partial hip replacement

Exclusion criteria

• r/o infection
• reoperation
• mental change

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 2 patient groups, including a placebo group

control group (group C)

Placebo Comparator group

Description:

control group will receive no medication preoperatively and during operation

Treatment:

Drug: none of medication preoperatively and intraoperatively

periarticular injecion group (group I)

Active Comparator group

Description:

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.

Treatment:

Drug: periarticular injection of multidrug regimen