Arthropathy of KneeNCT05105074
Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
A study testing Intrathecal Morphine in people with Arthropathy of Knee and Arthropathy of Hip, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Intrathecal Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Being tested
- Intrathecal Morphine, Placebo
- Keywords
- Arthroplasty, Knee, Hip, Intrathecal Morphine, Urinary retention, Opioid
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
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.
PlaceboDrug
Group 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | One group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia. Receives: Drug: Intrathecal Morphine |
| Placebo | Placebo comparator | One group will receive normal saline 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Duration of stay in the hospital in hours
Measured: From admission to the hospital until discharge, an average of 3 days
Secondary outcomes (4)
Incidence of opioid related side effects
Nausea, Vomiting, Constipation, Difficulty passing urine, Difficulty concentrating, Dizziness, Drowsiness, Feeling confused, Fatigue, Itchiness, Dry mouth, Headache.
Measured: 48 Hours post operatively
Time from Spinal Anesthesia to bladder catheterization
Time from Spinal Anesthesia to bladder catheterization (Foley catheterization or In and Out catheterization ) in hours.
Measured: During the hospital admission, an average of 3 days
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
Measured: 48 Hours post operatively
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).
Measured: At the time of discharge from hospital, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start19 Jan 2019
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105074
- Sponsor's protocol ID
- 18-0116-A
- Status last verified
- May 2022
- First submitted
- 28 Sep 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Petros JG, Rimm EB, Robillard RJ. Factors influencing urinary tract retention after elective open cholecystectomy. Surg Gynecol Obstet. 1992 Jun;174(6):497-500.
PubMed 1350689Huang 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.
PubMed 28234591Murphy 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.
PubMed 14633547David 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.
PubMed 27047216Min 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.
PubMed 27536639McCartney 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.
PubMed 21903643Jia 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.
PubMed 28254422
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Intrathecal Morphine Increase the Length of Hospital Stay in Fast Track Orthopedic Procedures?
- ClinicalTrials.gov ID
- NCT05105074
- Acronym / sponsor ID
- 18-0116-A
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Keywords
- Arthroplasty, Knee, Hip, Intrathecal Morphine, Urinary retention, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Active comparator | Drug: Intrathecal MorphineOne group will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia. |
| Placebo | Placebo comparator | Drug: PlaceboOne group will receive normal saline 100 mcg in addition to the standard dose of bupivacaine and fentanyl 15 mcg for spinal anesthesia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal MorphineGroup 1 - Patients will receive intrathecal morphine 100 mcg in addition to the standard dose of bupivacaine and 15 mcg of fentanyl for spinal anesthesia. | Drug | Intrathecal Morphine |
| PlaceboGroup 2 - Patients will not receive intrathecal morphine. Patients will receive only bupivacaine and 15 mcg of fentanyl for spinal anesthesia. | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Incidence of opioid related side effects
Time frame: 48 Hours post operatively
Time from Spinal Anesthesia to bladder catheterization
Time frame: 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
Overall feeling/ satisfaction about pain treatment
Time frame: At the time of discharge from hospital, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 1350689Petros JG, Rimm EB, Robillard RJ. Factors influencing urinary tract retention after elective open cholecystectomy. Surg Gynecol Obstet. 1992 Jun;174(6):497-500.
- Background: PubMed 28234591Huang 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.
- Background: PubMed 14633547Murphy 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.
- Background: PubMed 27047216David 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.
- Background: PubMed 27536639Min 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.
- Background: PubMed 21903643McCartney 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.
- Background: PubMed 28254422Jia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine in people with Arthropathy of Knee and Arthropathy of Hip, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: From admission to the hospital until discharge, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105074, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.