Spinal Anesthetic for Hip and Knee Replacement Surgery - Intrathecal Morphine or Hydromorphone

NCT04280939 | Withdrawn

• 1 other identifier: 19-20-06-012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the current healthcare system, a short length of stay is paramount, for medical, functional, and financial reasons. Most patients undergoing hip and knee replacement at Hôpital Montfort institution receive spinal anesthetic, with intrathecal morphine for enhanced analgesia. However, morphine can cause urinary retention, nausea or vomiting resulting in increased length of stay (LOS). Based mainly on local experience, The investigators believe hydromorphone may be a good alternative (1). According to the literature review, no adult study compares morphine and hydromorphone. QUESTIONS Does intrathecal hydromorphone lead to equal or better pain control/post-operative function, with fewer side effects than morphine? OBJECTIVES. Primary objective: to demonstrate that hydromorphone is the choice narcotic for spinal anesthesia for arthroplasty patients. Secondary objectives:

• increased patient satisfaction
• decreased hospital length of stay METHODOLOGY The investigators propose a prospective randomized double-blind trial with three groups of 155 patients each undergoing total hip arthroplasty (THA), total knee arthroplasty (TKA), or unicompartmental knee arthroplasty (UKA), striving for similar proportions of each procedure in all three groups.
• Group 1: spinal anesthetic with standard painkillers, without intrathecal narcotics (ie "placebo" group)
• Group 2: spinal anesthetic with intrathecal morphine
• Group 3: spinal anesthetic with intrathecal hydromorphone The primary outcome measure will be urinary retention. Secondary outcome measures will be nausea/vomiting, pain control, post-operative function and length of stay. RESULTS The investigators expect to show that intrathecal hydromorphone will provide the best combination of post-operative patient pain control and function, with diminished negative side effects. They hope to extrapolate this to a potential out-patient arthroplasty program.

Conditions

Spinal Anesthesia

Keywords

knee replacement; hip replacement; spinal anesthesia

Outcome Measures

Primary Outcomes (7)

• Urinary retention

  measured with bladder scan, number of catheterizations required (yes/no)

  immediately after surgery

• Nausea and vomiting

  use of anti-emetics - episodes of nausea and vomiting will be reported by nurses, use of anti-emetics will be recorded (yes/no, count)

  immediately after surgery

• Pain scores

  visual analog pain scale (ranges from 0=no pain to 10= worst pain ever), use of analgesics (yes/no, count)

  before surgery

• Pain scores

  visual analog pain scale (ranges from 0=no pain to 10= worst pain ever), use of analgesics (yes/no, count)

  immediately after surgery

• Pain scores

  visual analog pain scale (ranges from 0=no pain to 10= worst pain ever), use of analgesics (yes/no, count)

  one day after surgery

• Specific patient-reported outcomes for arthroplasty

  Oxford Knee/Hip Score (ranges from 0=worst outcome to 48= better outcome)

  immediately after surgery

• Specific patient-reported outcomes for arthroplasty

  Oxford Knee/Hip Score (ranges from 0=worst outcome to 48= better outcome)

  one month after surgery

Study Arms (3)

spinal anesthetic without intrathecal narcotic

ACTIVE COMPARATOR

spinal anesthetic with standard painkillers without intrathecal narcotics

Procedure: spinal anesthesia

spinal anesthetic with morphine

EXPERIMENTAL

spinal anesthetic with 100 micrograms of intrathecal morphine

Procedure: spinal anesthesia

spinal anesthetic with hydromorphone

EXPERIMENTAL

spinal anesthetic with 20 micrograms of intrathecal hydromorphone

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

prospective randomized double-blind study of patients undergoing total hip or knee replacement, as well as partial knee replacements (medial, lateral, patellafemoral, or bilateral). All groups will be matched for age, sex, American Society of Anesthesiologists class, and type of surgery. An attempt will be made to achieve a similar proportion of THA, TKA, and partial knee replacements in each group. We will randomize patients to one group of spinal anesthesia protocole.

spinal anesthetic with hydromorphone; spinal anesthetic with morphine; spinal anesthetic without intrathecal narcotic

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients having a hip or knee replacement at Hôpital Montfort,
• candidates for spinal anaesthetic,
• and who give their consent

You may not qualify if:

• allergy to morphine or hydromorphone;
• spinal anesthetic is contra-indicated;
• patients who cannot or refuse to give consent;
• all emergency cases.

Sponsors & Collaborators

• Hopital Montfort: lead

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 21, 2020
• Study Start: April 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share