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

NCT03427463 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro00072393
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

  This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.

  24 hours

Secondary Outcomes (5)

• Time to First Ambulation After C-section

  up to 48 hours

• Opioid Medication Given During the Participant's Hospital Stay.

  From the time of the procedure through discharge, up to 48 hours.

• Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.

  24-hours post operatively and 48-hours post operatively

• Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)

  24 hours post operavtively

• Overall Patient Satisfaction With Pain Control

  48 hours post-op

Study Arms (2)

receiving 0.1 mg IT morphine

ACTIVE COMPARATOR

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

Drug: receiving 0.1 mg IT morphine

recieving 0.05 mg IT morphine

EXPERIMENTAL

Patients will receive 0.05 mg of intrathecal morphine

Drug: recieving 0.05 mg IT morphine

Interventions

receiving 0.1 mg IT morphine DRUG

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

receiving 0.1 mg IT morphine

recieving 0.05 mg IT morphine DRUG

Patients will receive 0.05 mg of intrathecal morphine

recieving 0.05 mg IT morphine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Katherine Hatter, M.D.
• Organization: Medical University of South Carolina

herbertk@musc.edu

(843) 792-5454

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 9, 2018
• Study Start: January 16, 2018
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-12

Locations

US (1)