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

NCT01112436 | Unknown Phase 4

• 1 other identifier: ChunaAngUH
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fracture

Keywords

Pain; preemptive; Postoperative; delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  Post Op 1 day

Secondary Outcomes (12)

• 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

Study Arms (2)

control group (group C)

PLACEBO COMPARATOR

control group will receive no medication preoperatively and during operation

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.

Drug: periarticular injection of multidrug regimen

Interventions

periarticular injection of multidrug regimen DRUG

periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg

Also known as: injection near the hip joint

periarticular injecion group (group I)

none of medication preoperatively and intraoperatively DRUG

Patients in Group C wil receive none of medication preoperatively and intraoperatively

Also known as: Patients in Group C wil receive none of medication

control group (group C)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• femoral neck fracture
• partial hip replacement

You may not qualify if:

• r/o infection
• reoperation
• mental change

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

ChungAng University

Seoul, 156-755, South Korea

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures; Pain; Delirium

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yong Chan Ha, M.D. & Ph.D.

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

  STUDY DIRECTOR

• Hyun Kang, M.D. & Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 28, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2010-04

Locations

KR (1)