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Intrathecal Morphine and Fentanyl for Knee Arthroplasty

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365115
Enrollment
111
Registered
2017-12-07
Start date
2018-01-01
Completion date
2019-02-01
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

spinal anesthesia, morphine, fentanyl, pain, knee

Brief summary

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

Interventions

DRUGIntrathecal morphine

Intrathecal morphine 100 mcg will be injected.

DRUGIntrathecal fentanyl

Intrathecal fentanyl 25 mcg will be injected.

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scores at 6 hour postoperativelyAt 6 hour postoperativelyPostoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).

Secondary

MeasureTime frameDescription
Patient-controlled analgesic device requirementsAt 6, 12, and 24 hour postoperativelyThe 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 nauseaAt 6, 12, and 24 hour postoperatively—
Postoperative pain scores at 12 and 24 hour postoperativelyAt 12 and 24 hour postoperativelyPostoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
Number of participants with pruritusAt 6, 12, and 24 hour postoperatively—
Number of participants with respiratory depressionAt 6, 12, and 24 hour postoperatively—
Number of participants with vomitingAt 6, 12, and 24 hour postoperatively—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026