Intrathecal Morphine and Fentanyl for Knee Arthroplasty

Knee Arthroplasty Clinical Trial

Official title:

Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365115
• Other study ID #: 201712001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 5, 2017
• Start date: January 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: December 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 111
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Drug:
• Intrathecal morphine
Intrathecal morphine 100 mcg will be injected.
• Intrathecal fentanyl
Intrathecal fentanyl 25 mcg will be injected.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores at 6 hour postoperatively	Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).	At 6 hour postoperatively
Secondary	Postoperative pain scores at 12 and 24 hour postoperatively	Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).	At 12 and 24 hour postoperatively
Secondary	Patient-controlled analgesic device requirements	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.	At 6, 12, and 24 hour postoperatively
Secondary	Number of participants with nausea		At 6, 12, and 24 hour postoperatively
Secondary	Number of participants with vomiting		At 6, 12, and 24 hour postoperatively
Secondary	Number of participants with pruritus		At 6, 12, and 24 hour postoperatively
Secondary	Number of participants with respiratory depression		At 6, 12, and 24 hour postoperatively