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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Cesarean Section

Treatments: Drug: receiving 0.1 mg IT morphine; Drug: recieving 0.05 mg IT morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03427463

Pro00072393

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 2 patient groups

receiving 0.1 mg IT morphine

Active Comparator group

Description:

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

Treatment:

Drug: receiving 0.1 mg IT morphine

recieving 0.05 mg IT morphine

Experimental group

Description:

Patients will receive 0.05 mg of intrathecal morphine

Treatment:

Drug: recieving 0.05 mg IT morphine