Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
Primary Purpose
Arthropathy of Knee, Arthropathy of Hip
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intrathecal Morphine
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Arthropathy of Knee focused on measuring Arthroplasty, Knee, Hip, Intrathecal Morphine, Urinary retention, Opioid
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intrathecal Morphine
Placebo
Arm Description
One group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia.
One group will receive normal saline 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia
Outcomes
Primary Outcome Measures
Hospital length of stay
Duration of stay in the hospital in hours
Secondary Outcome Measures
Incidence of opioid related side effects
Nausea, Vomiting, Constipation, Difficulty passing urine, Difficulty concentrating, Dizziness, Drowsiness, Feeling confused, Fatigue, Itchiness, Dry mouth, Headache.
Time from Spinal Anesthesia to bladder catheterization
Time from Spinal Anesthesia to bladder catheterization (Foley catheterization or In and Out catheterization ) in hours.
Pain scores measured at rest and movement twice a day
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
Overall feeling/ satisfaction about pain treatment
Patient satisfaction from pain management during hospital stay, from score of 1(very dissatisfied) to score of 6 (Very satisfied).
Full Information
NCT ID
NCT05105074
First Posted
September 28, 2021
Last Updated
May 10, 2022
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05105074
Brief Title
Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
Official Title
Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Arthropathy of Hip
Keywords
Arthroplasty, Knee, Hip, Intrathecal Morphine, Urinary retention, Opioid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal Morphine
Arm Type
Active Comparator
Arm Description
One group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One group will receive normal saline 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Group 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia.
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
Duration of stay in the hospital in hours
Time Frame
From admission to the hospital until discharge, an average of 3 days
Secondary Outcome Measure Information:
Title
Incidence of opioid related side effects
Description
Nausea, Vomiting, Constipation, Difficulty passing urine, Difficulty concentrating, Dizziness, Drowsiness, Feeling confused, Fatigue, Itchiness, Dry mouth, Headache.
Time Frame
48 Hours post operatively
Title
Time from Spinal Anesthesia to bladder catheterization
Description
Time from Spinal Anesthesia to bladder catheterization (Foley catheterization or In and Out catheterization ) in hours.
Time Frame
During the hospital admission, an average of 3 days
Title
Pain scores measured at rest and movement twice a day
Description
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
Time Frame
48 Hours post operatively
Title
Overall feeling/ satisfaction about pain treatment
Description
Patient satisfaction from pain management during hospital stay, from score of 1(very dissatisfied) to score of 6 (Very satisfied).
Time Frame
At the time of discharge from hospital, an average of 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
1350689
Citation
Petros JG, Rimm EB, Robillard RJ. Factors influencing urinary tract retention after elective open cholecystectomy. Surg Gynecol Obstet. 1992 Jun;174(6):497-500.
Results Reference
background
PubMed Identifier
28234591
Citation
Huang A, Ryu JJ, Dervin G. Cost savings of outpatient versus standard inpatient total knee arthroplasty. Can J Surg. 2017 Feb;60(1):57-62. doi: 10.1503/cjs.002516.
Results Reference
background
PubMed Identifier
14633547
Citation
Murphy PM, Stack D, Kinirons B, Laffey JG. Optimizing the dose of intrathecal morphine in older patients undergoing hip arthroplasty. Anesth Analg. 2003 Dec;97(6):1709-1715. doi: 10.1213/01.ANE.0000089965.75585.0D.
Results Reference
background
PubMed Identifier
27047216
Citation
David M, Arthur E, Dhuck R, Hemmings E, Dunlop D. High rates of postoperative urinary retention following primary total hip replacement performed under combined general and spinal anaesthesia with intrathecal opiate. J Orthop. 2015 Nov 18;12(Suppl 2):S157-60. doi: 10.1016/j.jor.2015.10.020. eCollection 2015 Dec.
Results Reference
background
PubMed Identifier
27536639
Citation
Min BW, Kim Y, Cho HM, Park KS, Yoon PW, Nho JH, Kim SM, Lee KJ, Moon KH. Perioperative Pain Management in Total Hip Arthroplasty: Korean Hip Society Guidelines. Hip Pelvis. 2016 Mar;28(1):15-23. doi: 10.5371/hp.2016.28.1.15. Epub 2016 Mar 31.
Results Reference
background
PubMed Identifier
21903643
Citation
McCartney CJ, McLeod GA. Local infiltration analgesia for total knee arthroplasty. Br J Anaesth. 2011 Oct;107(4):487-9. doi: 10.1093/bja/aer255. No abstract available.
Results Reference
background
PubMed Identifier
28254422
Citation
Jia XF, Ji Y, Huang GP, Zhou Y, Long M. Comparison of intrathecal and local infiltration analgesia by morphine for pain management in total knee and hip arthroplasty: A meta-analysis of randomized controlled trial. Int J Surg. 2017 Apr;40:97-108. doi: 10.1016/j.ijsu.2017.02.060. Epub 2017 Feb 24.
Results Reference
background
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Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
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