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Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

Primary Purpose

Cesarean Section

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
receiving 0.1 mg IT morphine
recieving 0.05 mg IT morphine
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • any parturient 18 years of age or older
  • undergoing elective cesarean delivery under spinal anesthesia
  • able to consent to the study and participate in the follow-up.

Exclusion Criteria:

  • any known allergy to morphine
  • general anesthesia
  • urgent or emergent cases
  • any bleeding diathesis or other coagulopathy
  • known G6PD deficiency
  • any known liver disease
  • known alcohol abuse or dependence
  • HELLP syndrome
  • thrombocytopenia or known platelet dysfunction
  • history or active gastrointestinal bleeding
  • acute kidney injury or chronic renal insufficiency
  • contraindication/refusal to spinal anesthestic
  • chronic pain
  • chronic narcotic use
  • illicit drug use
  • allergy to any study related medications

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

receiving 0.1 mg IT morphine

recieving 0.05 mg IT morphine

Arm Description

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

Patients will receive 0.05 mg of intrathecal morphine

Outcomes

Primary Outcome Measures

Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery.

Secondary Outcome Measures

time to first ambulation
opiate consumption
subjective pain rating using visual analogue scales (VAS)
presence of opiate side effects (nausea, vomiting, and pruritus)
overall patient satisfaction with pain control

Full Information

First Posted
January 16, 2018
Last Updated
March 14, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03427463
Brief Title
Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
Official Title
Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

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
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This study will be conducted as a randomized controlled single-blinded clinical trial with patients being randomized to receive either 0.1 or 0.05 mg of IT morphine.
Masking
Participant
Masking Description
Patients will be blinded
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
receiving 0.1 mg IT morphine
Arm Type
Active Comparator
Arm Description
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
Arm Title
recieving 0.05 mg IT morphine
Arm Type
Experimental
Arm Description
Patients will receive 0.05 mg of intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
receiving 0.1 mg IT morphine
Intervention Description
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
recieving 0.05 mg IT morphine
Intervention Description
Patients will receive 0.05 mg of intrathecal morphine
Primary Outcome Measure Information:
Title
Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
time to first ambulation
Time Frame
up to 48 hours
Title
opiate consumption
Time Frame
24 and 48 hours
Title
subjective pain rating using visual analogue scales (VAS)
Time Frame
24 hours post operatively
Title
presence of opiate side effects (nausea, vomiting, and pruritus)
Time Frame
24 hours post operavtively
Title
overall patient satisfaction with pain control
Time Frame
48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Inclusion criteria consist of any parturient 18 years of age or older who is undergoing elective cesarean delivery under spinal anesthesia and is able to consent to the study and participate in the follow-up.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: any parturient 18 years of age or older undergoing elective cesarean delivery under spinal anesthesia able to consent to the study and participate in the follow-up. Exclusion Criteria: any known allergy to morphine general anesthesia urgent or emergent cases any bleeding diathesis or other coagulopathy known G6PD deficiency any known liver disease known alcohol abuse or dependence HELLP syndrome thrombocytopenia or known platelet dysfunction history or active gastrointestinal bleeding acute kidney injury or chronic renal insufficiency contraindication/refusal to spinal anesthestic chronic pain chronic narcotic use illicit drug use allergy to any study related medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Nitchie
Phone
843-876-1869
Email
nitchie@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Herbert, MD
Phone
843 792 5699
Email
herbertk@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Nitchie
Phone
843-792-1869
Email
nitchie@musc.edu
First Name & Middle Initial & Last Name & Degree
Katherine Herbert, MD

12. IPD Sharing Statement

Learn more about this trial

Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

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