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

NCT05105074 | Completed

• 1 other identifier: 18-0116-A
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Arthropathy of Hip

Keywords

Arthroplasty; Knee; Hip; Intrathecal Morphine; Urinary retention; Opioid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of opioid related side effects

  48 Hours post operatively

• Time from Spinal Anesthesia to bladder catheterization

  During the hospital admission, an average of 3 days

• Pain scores measured at rest and movement twice a day

  48 Hours post operatively

• Overall feeling/ satisfaction about pain treatment

  At the time of discharge from hospital, an average of 3 days

Study Arms (2)

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.

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

Drug: Placebo

Interventions

Intrathecal Morphine DRUG

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.

Intrathecal Morphine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (7)

• Petros JG, Rimm EB, Robillard RJ. Factors influencing urinary tract retention after elective open cholecystectomy. Surg Gynecol Obstet. 1992 Jun;174(6):497-500.

  PMID: 1350689 BACKGROUND

• 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.

  PMID: 28234591 BACKGROUND

• 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.

  PMID: 14633547 BACKGROUND

• 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.

  PMID: 27047216 BACKGROUND

• 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.

  PMID: 27536639 BACKGROUND

• 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.

  PMID: 21903643 BACKGROUND

• 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.

  PMID: 28254422 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 3, 2021
• Study Start: January 19, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CA (1)