Phase 4
N=72
Intrathecal Morphine for Cesarean Delivery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT05069012 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Duration of Pain Relief — 24.5; 29.4; 32 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine Sulfate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Pain Relief |
24.5; 29.4; 32 | — |
| SECONDARY Pain Scores |
2.2; 1.8; 1.9 | — |
| SECONDARY Quality of Recovery |
72; 93; 95 | — |
| SECONDARY Nausea |
4.3; 8.7; 12.5 | — |
| SECONDARY Pruritus |
8.7; 4.3; 4.1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05069012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.