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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105074
• Other study ID #: 18-0116-A
• Status: Completed
• Phase: N/A
• Start date: January 19, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: May 2022
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Duration of stay in the hospital in hours	From admission to the hospital until discharge, an average of 3 days
Secondary	Incidence of opioid related side effects	Nausea, Vomiting, Constipation, Difficulty passing urine, Difficulty concentrating, Dizziness, Drowsiness, Feeling confused, Fatigue, Itchiness, Dry mouth, Headache.	48 Hours post operatively
Secondary	Time from Spinal Anesthesia to bladder catheterization	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
Secondary	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	48 Hours post operatively
Secondary	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).	At the time of discharge from hospital, an average of 3 days