Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?

May 10, 2022 updated by: Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

This is a clinical trial of intrathecal morphine for patients Patient with primary as well as revision knee and hip arthroplasty under regional anesthesia. This study would include a total of 134 patients. It is the intention to randomize these patients postoperatively into 2 groups of patients:

Group 1 - Patients will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and 15 mcg of fentanyl for spinal anesthesia.

Group 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia.

It is postulated that the use of intrathecal morphine may be associated with an increase length of stay in the hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedures:

Preoperative phase- The patients will receive the consent form together with the standard sheet in the pre-admission unit or remotely via telephone or email, usually one week before surgery, explaining intrathecal morphine and its benefits and drawbacks. These patients will receive an educational booklet regarding the "fast track protocol" which includes clear instruction related to their upcoming surgery. The material covers a wide range of topics such as instructions related to fasting for solids and liquids before coming for surgery, the expectation of pain relief and physiotherapy, types of anesthesia and expected length of hospital stay. Upon hospital admission, one hour before the procedure, patients will receive gabapentin 300mg, celecoxib 400mg (will be reduced to celecoxib 200mg in patients ≥ 65 years old) and acetaminophen 1000mg orally.

Intraoperative phase- Surgical procedures to be included in the study are elective primary as well as revision arthroplasty of knee and hip joints under spinal anesthesia with or without sedation. Patient will be randomized to one of two groups. One group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia and another group will not receive intrathecal morphine. Upon prosthesis implant, the surgeon will infiltrate periarticular 100 ml (40 ml bupivacaine 0.5% + 60 ml of normal saline) as per the orthopedic protocol. Sedation will be titrated to keeping modified Ramsay sedations score (RSS) between 3 and 5.

Postoperative phase- upon emergence from anesthesia patients will be taken to the recovery room. As per our hospital protocol, the patient will be catheterized if the bladder residual volume by ultrasound is 500ml or more. Post-operative pain score and opioid requirements and complications including urinary retention, vomiting and respiratory depression will be recorded. Overall duration of stay in the hospital will be noted. If any patient requires catheterization of bladder, the duration of catheter requirement and frequency of catheterization will be monitored and recorded.

Study Type

Interventional

Enrollment (Actual)

104

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-3
  • Age 18 to 85 years
  • BMI 18 to 40 kg/cm2
  • Patient with primary as well as revision knee and hip arthroplasty under regional anesthesia only.
  • Provision of written informed consent.

Exclusion Criteria:

  • Language barrier or difficulty in communication: inability to read write or speak English
  • Allergy to morphine
  • Patients under increased risk for respiratory depression with intrathecal morphine (central apnea)
  • Patients with pre-existing urinary problems
  • Women of child bearing potential not on birth control
  • Patients with chronic pain who are currently on pain medications
  • Patients with cognitive impairment
  • Patients who have alcohol and/or other substance dependency

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal Morphine
One group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia.
Drug: Intrathecal Morphine
Group 1 - Patients will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and 15 mcg of fentanyl for spinal anesthesia.
Placebo Comparator: Placebo
One group will receive normal saline 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia
Drug: Placebo
Group 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: From admission to the hospital until discharge, an average of 3 days
Duration of stay in the hospital in hours
From admission to the hospital until discharge, an average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of opioid related side effects
Time Frame: 48 Hours post operatively
Nausea, Vomiting, Constipation, Difficulty passing urine, Difficulty concentrating, Dizziness, Drowsiness, Feeling confused, Fatigue, Itchiness, Dry mouth, Headache.
48 Hours post operatively
Time from Spinal Anesthesia to bladder catheterization
Time Frame: During the hospital admission, an average of 3 days
Time from Spinal Anesthesia to bladder catheterization (Foley catheterization or In and Out catheterization ) in hours.
During the hospital admission, an average of 3 days
Pain scores measured at rest and movement twice a day
Time Frame: 48 Hours post operatively
Based on Verbal Analogue Scale (VAS) scoring system (0-10), where score of 0 refers to no pain and a score of 10 refers to the worst pain imaginable
48 Hours post operatively
Overall feeling/ satisfaction about pain treatment
Time Frame: At the time of discharge from hospital, an average of 3 days
Patient satisfaction from pain management during hospital stay, from score of 1(very dissatisfied) to score of 6 (Very satisfied).
At the time of discharge from hospital, an average of 3 days

Collaborators and Investigators

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

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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)

January 19, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0116-A

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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