Intrathecal Morphine and Fentanyl for Knee Arthroplasty

December 5, 2017 updated by: Hyun-Chang Kim, Keimyung University Dongsan Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: intrathecal fentanyl
Drug: Intrathecal fentanyl
Intrathecal fentanyl 25 mcg will be injected.
ACTIVE_COMPARATOR: intrathecal morphine
Drug: Intrathecal morphine
Intrathecal morphine 100 mcg will be injected.
EXPERIMENTAL: intrathecal morphine and fentantyl
Drug: Intrathecal fentanyl
Intrathecal fentanyl 25 mcg will be injected.
Drug: Intrathecal morphine
Intrathecal morphine 100 mcg will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores at 6 hour postoperatively
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores at 12 and 24 hour postoperatively
Time Frame: 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
Patient-controlled analgesic device requirements
Time Frame: 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.
At 6, 12, and 24 hour postoperatively
Number of participants with nausea
Time Frame: At 6, 12, and 24 hour postoperatively
At 6, 12, and 24 hour postoperatively
Number of participants with vomiting
Time Frame: At 6, 12, and 24 hour postoperatively
At 6, 12, and 24 hour postoperatively
Number of participants with pruritus
Time Frame: At 6, 12, and 24 hour postoperatively
At 6, 12, and 24 hour postoperatively
Number of participants with respiratory depression
Time Frame: At 6, 12, and 24 hour postoperatively
At 6, 12, and 24 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (ACTUAL)

December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201712001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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