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Intrathecal Morphine for Cesarean Delivery

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine Sulfate
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cesarean, morphine, multimodal analgesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

50 micrograms

150 micrograms

250 micrograms

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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'
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.
Nausea
Incidence of nausea and vomiting requiring treatment with a medication
Pruritus
Incidence of pruritus requiring treatment with a medication

Full Information

First Posted
September 25, 2021
Last Updated
January 19, 2022
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05069012
Brief Title
Intrathecal Morphine for Cesarean Delivery
Official Title
Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
cesarean, morphine, multimodal analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization maintained in the research pharmacy. Blinded syringe delivered to the investigator for the study.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50 micrograms
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Arm Title
150 micrograms
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Arm Title
250 micrograms
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Intervention Description
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
Primary Outcome Measure Information:
Title
Duration of pain relief
Description
Time to patient request for first dose of oral rescue pain medicine
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain scores
Description
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
Title
Quality of recovery
Description
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.
Time Frame
24 hours
Title
Nausea
Description
Incidence of nausea and vomiting requiring treatment with a medication
Time Frame
24 hours
Title
Pruritus
Description
Incidence of pruritus requiring treatment with a medication
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Hess
Phone
6172832126
Email
phess@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip E Hess, MD
Phone
617-667-3112
Email
phess@bidmc.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Intrathecal Morphine for Cesarean Delivery

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