Intrathecal Morphine and Fentanyl for Knee Arthroplasty

Not Applicable

• Conditions: Knee Arthroplasty
• Interventions: Drug: Intrathecal fentanyl; Drug: Intrathecal morphine

• Registration Number: NCT03365115
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Patients scheduled total knee replacement under spinal anesthesia
• ASA I-III

Exclusion Criteria

• Coagulopathy
• Heart disease
• Liver disease
• Kidney disease
• Infection
• Psychological disorder
• Allergy to bupivacaine
• Allergy to morphine
• Allergy to fentanyl
• Inability to use patient-controlled analgesic device
• Opioids due to chronic pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrathecal fentanyl	Intrathecal fentanyl	-
intrathecal morphine	Intrathecal morphine	-
intrathecal morphine and fentantyl	Intrathecal morphine	-
intrathecal morphine and fentantyl	Intrathecal fentanyl	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores at 6 hour postoperatively	At 6 hour postoperatively	Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores at 12 and 24 hour postoperatively	At 12 and 24 hour postoperatively	Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
Patient-controlled analgesic device requirements	At 6, 12, and 24 hour postoperatively	The requirements of patient-controlled analgesic device will be measured. Morphine will be used for patient-controlled analgesic device. Total dose of morphine used at 6, 12, and 24 hour postoperatively will be measured.
Number of participants with respiratory depression	At 6, 12, and 24 hour postoperatively
Number of participants with vomiting	At 6, 12, and 24 hour postoperatively
Number of participants with nausea	At 6, 12, and 24 hour postoperatively
Number of participants with pruritus	At 6, 12, and 24 hour postoperatively