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NCT Number: NCT03592992

Spinal Hydromorphone Versus Morphine for Post-Cesarean Delivery Analgesia

Morphine is usually used for pain relief after cesarean delivery. However, sometimes it is not available, the patient might be allergic to morphine or intolerant to its side effects. Hydromorphone, another drug from the same class, might be used alternatively, but we need to prove that it is not inferior to morphine.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Victoria Hospital- LHSC

London, Ontario, N6A 5A5, Canada

About this study

Spinal or intrathecal (IT) morphine is the most commonly used opioid for post-cesarean delivery analgesia. Factors that contribute to its widespread use include a favorable pharmacokinetic profile with duration of action up to 24 hours, ease of administration (during spinal block for surgical anesthesia) and low cost. Most providers administer 100 to 200 mcg of IT morphine for cesarean delivery analgesia with excellent analgesic results. Nevertheless, subarachnoid use of morphine is not without adverse events. While dose-dependent respiratory depression is the most worrisome complication, other side effects such as pruritus, nausea, vomiting and urinary retention can be bothersome during early puerperium. Furthermore, shortages of preservative free morphine in the United States has led clinicians to seek a reasonable alternative.

For the last 20 years, spinal hydromorphone has been successfully used for chronic pain associated with neoplasms. Its use for post-cesarean analgesia has been successfully reported. However, data regarding its efficacy in the IT space for post-cesarean analgesia is scarce. In the past, doses of 40 to 100 mcg have been reported to provide adequate postoperative pain relief with minimal side effects. In a recent study, the Effective Dose in 90% of patients has been established for both Hydromorphone and Morphine to be 75 mcg and 150 mcg, respectively.

No prospective studies have been conducted to specifically establish non-inferiority of hydromorphone when compared to morphine for post- cesarean analgesia. In addition, while all opioids share the same side effect profile, the frequency of those events are unknown for IT hydromorphone.

The current proposal is a blinded randomized controlled trial of intrathecal hydromorphone versus morphine in term pregnant women undergoing elective cesarean deliveries under spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years; American Society of Anesthesiologist's Physical Status (ASA-PS) < 3; Term pregnancy (> 37 weeks gestational age); Elective cesarean delivery; Spinal Anesthesia;

Exclusion criteria

  • Documented allergy or severe intolerance to opioids; Intra-operative conversion to a general anesthetic technique; Chronic pain syndrome with baseline pain levels >3 on a visual analogue scale (0-10 cm); History of opioid use during this pregnancy; Allergy or intolerance to NSAIDS or acetaminophen; Morbid obesity- Body Mass Index (BMI) >40.

Treatment and study plan

Spinal Hydromorphone

Drug

75 mcg of hydromorphone will be prepared in a non-identifiable syringe by central hospital pharmacy. The resulting solution will then be added to the spinal anesthetic mixture(fentanyl 15 mcg and 0.75% hyperbaric bupivacaine 1.4-1.6 mcg at the discretion of the attending anesthesiologist, adjusted to height and weight)

Spinal Morphine

Drug

150 mcg of morphine will be prepared in a non-identifiable syringe by central hospital pharmacy.The resulting solution will be added to the spinal anesthetic mixture (fentanyl 15 mcg and 0.75% hyperbaric bupivacaine 1.4-1.6 mcg at the discretion of the attending anesthesiologist, adjusted to height and weight)

Primary outcomes

  1. Difference in the Average Numeric Rating Score (0-10 , where 0=no pain and 10= maximum pain) during the first 24 hours.

    Time frame: 24 hours after spinal anesthesia.

    This is defined as the between- group difference in the average pain scores on a 0-10 Numeric Rating Scale, as assessed by a nurse, anesthesia consultant or trainee 24 hours after spinal anesthesia.

Secondary outcomes

  1. Difference in NRS pain scores at specific time points in the first 24 hours.

    Time frame: immediately after surgery (in PACU), 6, 12 and 18 hours after spinal anesthesia is given.

    This is defined as the between- group difference in the mean pain scores on a 0-10 Numeric Rating Scale, as assessed by a nurse, anesthesia consultant or trainee immediately after surgery (in the Post-Anesthesia Care Unit) and at 6, 12, 18 and 24 hours after spinal anesthesia.

  2. Time-to-first oral opioid analgesic request

    Time frame: Measured in hours from the time of spinal anesthetic until patient request for prescribed oral opioid analgesia, up to 24 hours from the spinal anesthetic .

    This is defined as the length of time between spinal anesthesia and the first time the subject requested additional opioid analgesia, up to 24 hours from the spinal anesthesia.

  3. Nausea and/or Vomiting that required treatment.

    Time frame: Absolute number of treatments required in the 24-hour time frame.

    Nausea/Vomiting episodes that required pharmacological treatment in the first 24 hours after spinal anesthesia

  4. Pruritus that required treatment.

    Time frame: Absolute number of treatments required in the 24-hour time frame.

    Pruritus episodes that required pharmacological treatment in the first 24 hours after spinal anesthesia

  5. Respiratory Depression

    Time frame: In post-anesthesia care unit (PACU), 6, 12, 18 and 24 hours after spinal anesthesia

    Respiratory Rate measured in breaths/minute)

  6. Apgar Scores

    Time frame: 1 and 5 minutes after birth.

    Neonatal Apgar scores at 1 and 5 minutes in a 1-10 interval scale

  7. Difference in Opioid Consumption in the first 24 hours

    Time frame: 24 hours after spinal anesthesia.

    This is defined as the between-group difference in the total amount of Oral Morphine Equivalents consumed in the first 24 hours after spinal anesthesia is given.

  8. Obstetric Quality of Recovery Score ObsQoR-11

    Time frame: 24 hours after spinal anesthesia.

    11-item questionnaire applied to subjects 24 hours after spinal anesthesia. Measured in a 0-110 scale

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Spinal Hydromorphone Versus Morphine for Post-Cesarean Delivery Analgesia: A Non-Inferiority Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2018
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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