Intrathecal Morphine for Unilateral Total Knee Arthroplasty

May 21, 2021 updated by: Suwimon Tangwiwat, Mahidol University

Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty

This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.

This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged more than 18 years old undergoing unilateral total knee arthroplasty
  • American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria:

  • Participants deny to enroll the study
  • Allergy to local anesthetics, opioid and NSAIDs
  • Hepatic disease
  • Contraindication for neuraxial block or adductor canal block
  • Uncontrolled cardiovascular disease
  • Creatinine clearance less than 50 ml/min

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: No IT morphine
Spinal block with 0.5% isobaric with no intrathecal morphine
Procedure: No IT morphine
Spinal block with bupivacaine and intrathecal morphine 0 ug
Drug: Morphine
intrathecal morphine
Drug: Bupivacaine
0.5 isobaric bupivacaine
EXPERIMENTAL: 50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Drug: Morphine
intrathecal morphine
Drug: Bupivacaine
0.5 isobaric bupivacaine
Procedure: 50 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 50 ug
EXPERIMENTAL: 100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Drug: Morphine
intrathecal morphine
Drug: Bupivacaine
0.5 isobaric bupivacaine
Procedure: 100 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 100 ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale
Time Frame: Within 48 hours
Numerical rating scale 0-10
Within 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine requirement
Time Frame: Within 48 hours
Systemic morphine requirement
Within 48 hours
Nausea vomiting
Time Frame: Within 48 hours
Incidence and severity of nausea and vomiting
Within 48 hours
Pruritus
Time Frame: Within 48 hours
Incidence and severity of pruritus
Within 48 hours

Collaborators and Investigators

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

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (ACTUAL)

July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 331/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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