Cesarean Delivery
Conditions
Keywords
methadone, morphine, intrathecal, cesarean
Brief summary
The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.
Interventions
DRUGIntravenous line (IV) Methadone
Subjects will receive standardized spinal anesthesia without intrathecal morphine (intrathecal 1.6-2 mL 0.75% bupivacaine + dextrose, 15 mcg fentanyl) and intravenous methadone (0.2mg/kg total body weight up to max dose of 20 mg, with saline added to make total volume 2 mL) The Intravenous line (IV) methadone will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
DRUGIntrathecal Morphine
Subjects will receive standardized spinal anesthesia with intrathecal morphine 150 micrograms and no methadone (2cc dose of IV normal saline) The Intravenous line (IV) saline will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English-speaking * Age over 18 years old * Scheduled cesarean delivery
Exclusion criteria
* Any contraindication to the administration of a spinal technique for anesthesia * History of intolerance or adverse reaction to opioid medications * History of chronic pain, opioid use \>30 OME/day, or substance use disorder * History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 \<92% on room air, or has a pre-existing oxygen requirement) * History of liver or kidney failure * Diagnosis of pre-eclampsia with current pregnancy * Depression requiring more than one medication * Planned use of CSE technique * BMI \>50.0 kg/m2 * ASA status IV, V * No prior history of an ECG demonstrating QTc \> 440ms * Surgical complication requiring conversion to general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | 24 hours post-delivery, 48 hours post-delivery | Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) pain score at rest | 12 hours, 24 hours, 36 hours, 48 hours, 7 days | A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced at rest and is measured on a Likert scale from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. |
| Numeric Rating Scale (NRS) for movement-evoked pain | 12 hours, 24 hours, 36 hours, 48 hours, 7 days | A Numeric Rating Scale (NRS) score for movement-evoked pain is a patient-reported item regarding the level of pain experienced with provoking maneuvers such as cough, inspiration/expiration, sitting up, knee flexion, hip flexion, rolling over in bed, and walking. The NRS is measured on a Likert scale from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. |
| Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool | 24 hours, 48 hours, 7 days | The Obstetric Quality of Recovery-10 (ObsQoR-10), is a patient-reported 10-item questionnaire used to assess quality of recovery following spinal administration of pain medication. Patients rate each recovery item on a scale of 0 to 10, with 0 = worst possible recovery and 10 = best possible recovery. Total score ranges from 0-100 with higher scores indicating a better recovery after childbirth. |
| Pruritus | 12 hours, 24 hours, 36 hours, 48 hours | The severity of pruritus post spinal administration will be patient-reported on a 4-point Likert scale where 0 = none and 3 = severe. |
| Richmond Agitation Sedation Scale (RASS) | 12 hours, 24 hours, 36 hours, 48 hours | The Richmond Agitation Sedation Scale (RASS) will be used to assess the level of alertness and agitated behavior in patients. The patient's level of consciousness and sedation are rated by care provider, ranging from a combative state (+4) to an unarousable state (-5), with a calm and alert score at 0. |
| Numeric Rating Scale (NRS) for pain in previous 24 hours | 12 hours, 24 hours, 36 hours, 48 hours, 7 days | A Numeric Rating Scale (NRS) score for highest level of pain is a patient-reported item regarding the level of pain experienced in the last 24 hours. The NRS is measured on a Likert scale from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. |
Countries
United States
Outcome results
None listed