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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427463
• Other study ID #: Pro00072393
• Status: Completed
• Phase: Early Phase 1
• Start date: January 16, 2018
• Est. completion date: August 3, 2023

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• receiving 0.1 mg IT morphine
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
• recieving 0.05 mg IT morphine
Patients will receive 0.05 mg of intrathecal morphine

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery.		24 hours
Secondary	time to first ambulation		up to 48 hours
Secondary	opiate consumption		24 and 48 hours
Secondary	subjective pain rating using visual analogue scales (VAS)		24 hours post operatively
Secondary	presence of opiate side effects (nausea, vomiting, and pruritus)		24 hours post operavtively
Secondary	overall patient satisfaction with pain control		48 hours