Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

NCT01960595 | Unknown Phase 4 DMC

• 1 other identifier: KMUH-IRB-20120357
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy and cost analysis of intravenous fentanyl combined with either local anesthesia infiltration or peroneal nerves block in patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with patients without local anesthetics administration perioperatively.

Conditions

Pain

Keywords

PCA,Nerve block,Hullax Valgus

Outcome Measures

Primary Outcomes (1)

• provides adequate pain relief and decreases fentanyl consumption

  Patients are subgrouping into groups of post-OP IV fentanyl PCA only, pretreatment of local bupivacaine infiltration and post-OP IV fentanyl PCA, and pretreatment of peroneal nerves block and post-OP IV fentanyl PCA. Resting pain and moving pain scores are measured by the numeric rating scale and classified into none, mild, moderate and severe pain four grades. Pains scale and side effects are recorded at time intervals of post-OP 0 hours, 6 hours, 12 hours, 24 hours, and 36 hours after surgery.

  including of surgery and 36 hours after surgery

Secondary Outcomes (1)

• incidence of side effects and complications

  intraoperatively and 36 hours after surgery

Other Outcomes (1)

• assessment of cost analysis among groups

  surgery period and 36 hours after surgery

Study Arms (3)

IV fentanyl PCA

EXPERIMENTAL

The patient receives post-OP IV fentanyl PCA

Procedure: IV fentanyl PCA

post-OP IV fentanyl PCA and local infiltration

ACTIVE COMPARATOR

pretreatment of local infiltration 0.25% bupivacaine 5 ml and post-OP IV fentanyl PCA

Procedure: local bupivacaine infiltration and post-OP IV fentanyl PCA

nerves block and post-OP IV fentanyl PCA

ACTIVE COMPARATOR

pretreatment of peroneal nerves 0.25% bupivacaine 10 ml and post-OP IV fentanyl PCA

Procedure: Nerve Blocks and post-OP IV fentanyl PCA

Interventions

IV fentanyl PCA PROCEDURE

IV fentanyl PCA

local bupivacaine infiltration and post-OP IV fentanyl PCA PROCEDURE

post-OP IV fentanyl PCA and local infiltration

Nerve Blocks and post-OP IV fentanyl PCA PROCEDURE

nerves block and post-OP IV fentanyl PCA

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with American Society of Anesthesiologists physical status I-III
• aged 20-65 years
• Requiring local anesthesia and PCA use
• No severe cardiac or pulmonary diseases
• BMI \<35 kg/m2

You may not qualify if:

• BMI ≧35 kg/m2
• age \> 65years
• allergy to opioid or local anesthetics

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

MeSH Terms

Conditions

Pain

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Peng Ju Huang, MD, PhD.

  Department of orthopaedic surgery, Kaohsiung Medical University, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: October 10, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 10, 2013

Record last verified: 2013-05

Locations

TW (1)