Intrathecal Morphine for Cesarean Delivery

NCT05069012 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2021P000688
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

cesarean; morphine; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of Pain Relief

  Time to patient request for first dose of oral rescue pain medicine

  72 hours after delivery

Secondary Outcomes (4)

• Pain Scores

  24 hours after delivery

• Quality of Recovery

  24 hours after delivery

• Nausea

  24 hours after delivery

• Pruritus

  24 hours after delivery

Study Arms (3)

50 micrograms

ACTIVE COMPARATOR

Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

Drug: Morphine Sulfate

150 micrograms

ACTIVE COMPARATOR

Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

Drug: Morphine Sulfate

250 micrograms

ACTIVE COMPARATOR

Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

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

150 micrograms; 250 micrograms; 50 micrograms

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Borrelli MC, Sprowell AJ, Moldysz A, Idris M, Armstrong SL, Kowalczyk JJ, Li Y, Hess PE. A randomized controlled trial of spinal morphine with an enhanced recovery pathway and its effect on duration of analgesia after cesarean delivery. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101309. doi: 10.1016/j.accpm.2023.101309. Epub 2023 Oct 18.

  PMID: 37863195 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Philip Hess
• Organization: Beth Israel Deaconess Medical Center

phess@bidmc.harvard.edu

617-667-3112

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization maintained in the research pharmacy. Blinded syringe delivered to the investigator for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective randomized

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: November 15, 2021
• Primary Completion: July 23, 2022
• Study Completion: July 23, 2022
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)