Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
- Conditions
- Cesarean Section
- Interventions
- Drug: recieving 0.05 mg IT morphineDrug: receiving 0.1 mg IT morphine
- Registration Number
- NCT03427463
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 229
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description recieving 0.05 mg IT morphine recieving 0.05 mg IT morphine Patients will receive 0.05 mg of intrathecal morphine receiving 0.1 mg IT morphine receiving 0.1 mg IT morphine Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
- Primary Outcome Measures
Name Time Method Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery. 24 hours 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.
- Secondary Outcome Measures
Name Time Method Time to First Ambulation After C-section up to 48 hours This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.
Opioid Medication Given During the Participant's Hospital Stay. From the time of the procedure through discharge, up to 48 hours. This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100. 24-hours post operatively and 48-hours post operatively Subjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) 24 hours post operavtively The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.
Overall Patient Satisfaction With Pain Control 48 hours post-op Patients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States