NCT03365115

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 30, 2017

Last Update Submit

December 5, 2017

Conditions

Knee Arthroplasty

Keywords

spinal anesthesiamorphinefentanylpainknee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Postoperative pain scores at 12 and 24 hour postoperatively

    At 12 and 24 hour postoperatively

  • Patient-controlled analgesic device requirements

    At 6, 12, and 24 hour postoperatively

  • Number of participants with nausea

    At 6, 12, and 24 hour postoperatively

  • Number of participants with vomiting

    At 6, 12, and 24 hour postoperatively

  • Number of participants with pruritus

    At 6, 12, and 24 hour postoperatively

  • +1 more secondary outcomes

Study Arms (3)

intrathecal fentanyl

ACTIVE COMPARATOR
Drug: Intrathecal fentanyl

intrathecal morphine

ACTIVE COMPARATOR
Drug: Intrathecal morphine

intrathecal morphine and fentantyl

EXPERIMENTAL
Drug: Intrathecal morphineDrug: Intrathecal fentanyl

Interventions

Intrathecal morphineDRUG

Intrathecal morphine 100 mcg will be injected.

intrathecal morphineintrathecal morphine and fentantyl
Intrathecal fentanylDRUG

Intrathecal fentanyl 25 mcg will be injected.

intrathecal fentanylintrathecal morphine and fentantyl

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12