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

Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: receiving 0.1 mg IT morphine; Drug: recieving 0.05 mg IT morphine

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Haley Nitchie; Phone Number: 843-876-1869; Email: nitchie@musc.edu
• Study Contact Backup: Name: Katherine Herbert, MD; Phone Number: 843 792 5699; Email: herbertk@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: receiving 0.1 mg IT morphine; Patients will receive the standard of care dose 0.1 mg of intrathecal morphine	Drug: receiving 0.1 mg IT morphine; Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
Experimental: recieving 0.05 mg IT morphine; Patients will receive 0.05 mg of intrathecal morphine	Drug: recieving 0.05 mg IT morphine; Patients will receive 0.05 mg of intrathecal morphine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
time to first ambulation	up to 48 hours
opiate consumption	24 and 48 hours
subjective pain rating using visual analogue scales (VAS)	24 hours post operatively
presence of opiate side effects (nausea, vomiting, and pruritus)	24 hours post operavtively
overall patient satisfaction with pain control	48 hours

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Pro00072393

Drug and device information, study documents

• 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