Intrathecal Morphine for Cesarean Delivery

Postoperative Pain Clinical Trial

Official title:

Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069012
• Other study ID #: 2021P000688
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: Philip Hess
• Phone: 6172832126
• Email: phess[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized double blinded non-inferiority study comparing the duration of pain relief when patients receive one of three doses of spinal morphine. Enrolled patients will be randomly assigned to receive either 50 mcg, 150 mcg, or 250 mcg. All patients will receive standardized postoperative care, including multimodal analgesia. The primary outcome will be the time until the patient requests additional opioid pain medications.

Description:

Prospective, randomized, double-blind, controlled trial, with a non-inferiority design. Patients will be randomly assigned to receive either intrathecal morphine 50 mcg, 150 mcg, or 250 mcg based on a pre-assigned randomization sequence. This medication will be administered as part of their spinal anesthesia for cesarean delivery. the patient, clinician who administers the spinal anesthesia, and investigator who follows the patient will all be blinded to the dose of medication. All patients will receive standard of care for cesarean delivery and routine nursing care. This includes: preoperative intravenous catheter placement with preoperative IV fluid, standard American Society of Anesthesiologists monitoring, and neuraxial anesthesia placement (either spinal or combined spinal epidural) in sterile fashion. Each patient will receive standard cesarean induction dose of intrathecal medication consisting of 1.5ml of 0.75% hyperbaric bupivacaine, fentanyl 25 mcg. At end of surgery, all patients will receive standard dose of ketorolac 30 mg IV and acetaminophen 1 gm IV and continue with redosing every 6 and 8 hours (respectively) for 24 hours. On arrival to PACU, all patients will receive standard nursing care with standard monitoring of side effects. On discharge from PACU, patients will be transferred to postpartum floor and receive standard nursing care and monitoring. Over the following 24 hours, the patient will receive all standard post-cesarean care. For treatment of breakthrough pain, medications will provided be per standard care: oxycodone 5-10 mg PO every four hours PRN for pain. If the patient is not comfortable after receiving oral oxycodone they will be assessed by an anesthesia provider for either regional nerve block or additional opioids, as a one-time dose or by patient controlled analgesia (PCA). For treatment for side effects, medications will provided be per standard care: ondansetron 4mg IV as first-line for nausea/vomiting, promethazine 6.25 mg IV or Haloperidol 0.5-1mg IV for refractory nausea/vomiting. Naloxone 0.04 mg IV for refractory pruritus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy women (ASA 2)
• Between 18 and 45 years old
• Singleton term pregnancies
• Planned neuraxial anesthesia

Exclusion Criteria:

• Refusal to participate
• Known allergy or contraindication to any medication used in the study
• Significant medical or obstetrical disease (ASA = 3)
• Opioid use disorder
• Chronic pain syndrome
• Daily or near daily opioid use within last 3 weeks.
• Patient receiving a Monoamine oxidase inhibitors (MOAi)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Morphine Sulfate
Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of pain relief	Time to patient request for first dose of oral rescue pain medicine	24 hours
Secondary	Pain scores	Visual analogue pain scores reported by the patient. Scale measured on a line from 0 to 100 mm, with 0 representing 'no pain' and 100 representing 'worst possible pain'	24 hours
Secondary	Quality of recovery	Quality of Recovery Score following Cesarean Delivery Questionnaire (ObsQoR-11). This is a multi-dimensional wellness scale ranging from 0 (worst) to 10 (best) along 12 axis items.	24 hours
Secondary	Nausea	Incidence of nausea and vomiting requiring treatment with a medication	24 hours
Secondary	Pruritus	Incidence of pruritus requiring treatment with a medication	24 hours