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Intrathecal Morphine for Cesarean Delivery

Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05069012
Enrollment
72
Registered
2021-10-06
Start date
2021-11-15
Completion date
2022-07-23
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

cesarean, morphine, multimodal analgesia

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.

Detailed 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.

Interventions

DRUGMorphine 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

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomization maintained in the research pharmacy. Blinded syringe delivered to the investigator for the study.

Intervention model description

Prospective randomized

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Duration of Pain Relief72 hours after deliveryTime to patient request for first dose of oral rescue pain medicine

Secondary

MeasureTime frameDescription
Pain Scores24 hours after deliveryVisual 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'
Quality of Recovery24 hours after deliveryQuality of Recovery Score following Cesarean Delivery Questionnaire (ObsQoR-11). This is a multi-dimensional wellness scale ranging from 0 (worst) to 120 (best) along 12 axis items.
Nausea24 hours after deliveryIncidence of nausea and vomiting requiring treatment with a medication
Pruritus24 hours after deliveryIncidence of pruritus requiring treatment with a medication

Countries

United States

Participant flow

Participants by arm

ArmCount
50 Micrograms
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery 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
23
150 Micrograms
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery 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
23
250 Micrograms
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery 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
24
Total70

Baseline characteristics

Characteristic50 Micrograms150 Micrograms250 MicrogramsTotal
Age, Continuous36.0 Years
STANDARD_DEVIATION 3.8
33.9 Years
STANDARD_DEVIATION 4.8
36.8 Years
STANDARD_DEVIATION 4.9
35.6 Years
STANDARD_DEVIATION 4.6
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants1 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants20 Participants23 Participants64 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants2 Participants2 Participants8 Participants
Race (NIH/OMB)
Black or African American
4 Participants1 Participants2 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants4 Participants0 Participants7 Participants
Race (NIH/OMB)
White
12 Participants16 Participants19 Participants47 Participants
Sex: Female, Male
Female
23 Participants23 Participants24 Participants70 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 230 / 24
other
Total, other adverse events
0 / 230 / 230 / 24
serious
Total, serious adverse events
0 / 230 / 230 / 24

Outcome results

Primary

Duration of Pain Relief

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

Time frame: 72 hours after delivery

ArmMeasureValue (MEDIAN)
50 MicrogramsDuration of Pain Relief24.5 hours
150 MicrogramsDuration of Pain Relief29.4 hours
250 MicrogramsDuration of Pain Relief32 hours
Secondary

Nausea

Incidence of nausea and vomiting requiring treatment with a medication

Time frame: 24 hours after delivery

ArmMeasureValue (NUMBER)
50 MicrogramsNausea4.3 percentage of participants
150 MicrogramsNausea8.7 percentage of participants
250 MicrogramsNausea12.5 percentage of participants
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'

Time frame: 24 hours after delivery

ArmMeasureValue (MEDIAN)
50 MicrogramsPain Scores2.2 score on a scale
150 MicrogramsPain Scores1.8 score on a scale
250 MicrogramsPain Scores1.9 score on a scale
Secondary

Pruritus

Incidence of pruritus requiring treatment with a medication

Time frame: 24 hours after delivery

ArmMeasureValue (NUMBER)
50 MicrogramsPruritus8.7 percentage of participants
150 MicrogramsPruritus4.3 percentage of participants
250 MicrogramsPruritus4.1 percentage of participants
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 120 (best) along 12 axis items.

Time frame: 24 hours after delivery

ArmMeasureValue (MEDIAN)
50 MicrogramsQuality of Recovery72 score on a scale
150 MicrogramsQuality of Recovery93 score on a scale
250 MicrogramsQuality of Recovery95 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026