Clinical trial NCT03427463: Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
Official title: Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cesarean Section
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 229
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
timeFrame: 24 hours
Secondary outcomes:
measure: Time to First Ambulation After C-section
timeFrame: up to 48 hours
measure: Opioid Medication Given During the Participant's Hospital Stay.
timeFrame: From the time of the procedure through discharge, up to 48 hours.
measure: Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
timeFrame: 24-hours post operatively and 48-hours post operatively
measure: Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
timeFrame: 24 hours post operavtively
measure: Overall Patient Satisfaction With Pain Control
timeFrame: 48 hours post-op
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: