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

• ClinicalTrials.gov Identifier: NCT03427463
• Recruitment Status: Recruiting
• First Posted: February 9, 2018
• Last Update Posted: April 12, 2021
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Katherine Herbert, MD, Medical University of South Carolina

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.

Condition or disease	Intervention/treatment	Phase
Cesarean Section	Drug: receiving 0.1 mg IT morphine; Drug: recieving 0.05 mg IT morphine	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (Participant)
• Masking Description: Patients will be blinded
• Primary Purpose: Treatment
• Official Title: Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
• Actual Study Start Date: January 16, 2018
• Estimated Primary Completion Date: February 1, 2022
• Estimated Study Completion Date: February 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery. [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. time to first ambulation [ Time Frame: up to 48 hours ]
2. opiate consumption [ Time Frame: 24 and 48 hours ]
3. subjective pain rating using visual analogue scales (VAS) [ Time Frame: 24 hours post operatively ]
4. presence of opiate side effects (nausea, vomiting, and pruritus) [ Time Frame: 24 hours post operavtively ]
5. overall patient satisfaction with pain control [ Time Frame: 48 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: 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.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Wanda Jones, RN; 843-876-1869; joneswr@musc.edu

Contact: Kathryn Bridges, MD; 843 792 5699; bridgek@musc.edu

Locations

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Wanda Jones, RN 843-792-1869 joneswr@musc.edu

Principal Investigator: Katherine Herbert, MD

Sponsors and Collaborators

Medical University of South Carolina

More Information

• Responsible Party: Katherine Herbert, MD, Assistant Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03427463
• Other Study ID Numbers: Pro00072393
• First Posted: February 9, 2018
• Last Update Posted: April 12, 2021
• Last Verified: April 2021

• 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

Additional relevant MeSH terms:

Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents