Cesarean Section
Conditions
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.
Interventions
DRUGreceiving 0.1 mg IT morphine
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
DRUGrecieving 0.05 mg IT morphine
Patients will receive 0.05 mg of intrathecal morphine
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Receiving 0.1 mg IT Morphine Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine | 101 |
| Recieving 0.05 mg IT Morphine Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine | 100 |
| Total | 201 |
Baseline characteristics
| Characteristic | Receiving 0.1 mg IT Morphine | Recieving 0.05 mg IT Morphine | Total |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 5.19 | 31.7 years STANDARD_DEVIATION 6.07 | 31.6 years STANDARD_DEVIATION 5.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 94 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Prior C-Section, yes | 65 Participants | 73 Participants | 138 Participants |
| Race/Ethnicity, Customized Black/African American | 24 Participants | 31 Participants | 55 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 68 Participants | 61 Participants | 129 Participants |
| Sex: Female, Male Female | 101 Participants | 100 Participants | 201 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 100 |
| other Total, other adverse events | 68 / 101 | 62 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 100 |
Outcome results
Primary
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
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.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Receiving 0.1 mg IT Morphine | Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery. | NA hours |
| Recieving 0.05 mg IT Morphine | Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery. | 23.5 hours |
Secondary
Opioid Medication Given During the Participant's Hospital Stay.
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.
Time frame: From the time of the procedure through discharge, up to 48 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Receiving 0.1 mg IT Morphine | Opioid Medication Given During the Participant's Hospital Stay. | 74 Participants |
| Recieving 0.05 mg IT Morphine | Opioid Medication Given During the Participant's Hospital Stay. | 74 Participants |
Secondary
Overall Patient Satisfaction With Pain Control
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
Time frame: 48 hours post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Receiving 0.1 mg IT Morphine | Overall Patient Satisfaction With Pain Control | 93.75 units on a scale |
| Recieving 0.05 mg IT Morphine | Overall Patient Satisfaction With Pain Control | 94.5 units on a scale |
Secondary
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.
Time frame: 24 hours post operavtively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Receiving 0.1 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Any post-op nausea and/or vomiting, or itching, yes | 68 participants |
| Receiving 0.1 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Post-Op nausea, yes | 21 participants |
| Receiving 0.1 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Pruritis, yes | 60 participants |
| Receiving 0.1 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Post-op vomiting, yes | 11 participants |
| Recieving 0.05 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Pruritis, yes | 58 participants |
| Recieving 0.05 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Any post-op nausea and/or vomiting, or itching, yes | 62 participants |
| Recieving 0.05 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Post-Op nausea, yes | 27 participants |
| Recieving 0.05 mg IT Morphine | Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus) | Post-op vomiting, yes | 12 participants |
Secondary
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
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.
Time frame: 24-hours post operatively and 48-hours post operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Receiving 0.1 mg IT Morphine | Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100. | 24-hours post-op | 47.9 units on a scale |
| Receiving 0.1 mg IT Morphine | Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100. | 48-hours post-op | 44.2 units on a scale |
| Recieving 0.05 mg IT Morphine | Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100. | 24-hours post-op | 49.6 units on a scale |
| Recieving 0.05 mg IT Morphine | Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100. | 48-hours post-op | 45.9 units on a scale |
Secondary
Time to First Ambulation After C-section
This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.
Time frame: up to 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Receiving 0.1 mg IT Morphine | Time to First Ambulation After C-section | 13.6 hours |
| Recieving 0.05 mg IT Morphine | Time to First Ambulation After C-section | 13.7 hours |