Caesarean Delivery
Conditions
Keywords
Buprenorphine, Suboxone, Subutex, Buprenex, Caesarean Delivery
Brief summary
More and more women are on buprenorphine or methadone during pregnancy for a history of opioid addiction. Currently, pain control after cesarean section for women already on these medications, if they need operative delivery, is a challenge due to the pharmacology of those drugs. They have higher pain scores and 45-47% higher opiates requirement. To improve pain control, some unique regional anesthesia techniques have been employed, besides opioid and non-opioid medication management through the oral, intravenous, and/or neuraxial (spinal or epidural) route. One is a TAP block ( transversus abdominis plane block), a regional anesthesia procedure in which long acting local anesthetic, such as ropivacaine, is injected on both sides of the patient's abdomen to numb the nerves supplying the abdominal wall, or the surgical site. Another is a patient - controlled epidural, a small flexible catheter that is inserted in the back into the epidural space near the spine, which bathes the spinal nerve roots with long acting local anesthetic, such as bupivacaine, and with an opioid, such as fentanyl, to numb the nerves going to the surgical site. Through an epidural pump, the patient receives a continuous infusion of local anesthetic and can delivery more medication as needed through a bolus feature. There have case reports, or case by case accounts, of these techniques, and it is suspected these techniques result in better pain control with minimal side effects. No clinical, human or animal, has evaluated these techniques in a controlled and through manner, either comparing the two techniques to each other or comparing them to the common care of opioid and non-opioid medication management through the oral, intravenous, and/or neuraxial route, including neuraxial hydromorphone or morphine.
Interventions
DRUGTAP Block
This intervention of a TAP block will be compared to the intervention of Common Care and to the intervention of Patient Controlled Epidural Analgesia
DRUGRopivacaine
The intervention of the Patient Controlled Epidural Analgesia will be compared to the intervention of a TAP block and the intervention of Common Care
DRUGAcetaminophen
Common ways to treat pain control after Cesarean Section include oral and IV opioids, non-narcotic adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen, and long-acting spinal or epidural opioids such as morphine. Due to the potential issues such as ineffectiveness and fear of respiratory depression, increasing the dosing of these opioids may not be ideal. The intervention of Common Care will be compared to the intervention of a TAP block and the intervention of Patient Controlled Epidural Analgesia
DRUGMorphine
Sponsors
Massachusetts General Hospital
Brigham and Women's Hospital
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anesthesiology Society of Anesthesiologist's Status of II or III * Maintenance methadone or buprenorphine during pregnancy * Regional anesthesia staff to perform a TAP block * Elective, non-urgent cesarean delivery via a Pfannenstiel incision under regional anesthesia
Exclusion criteria
* Emergency cesarean section * Laboring patients who are now having to delivery operatively * Patients with a BMI over 50 * Patients with allergies to any of the study medications * Patients under 18 years old * Patients with multiple gestations * Patients undergoing general anesthesia * Patients who had contraindications for either an epidural or a TAP block as in coagulopathies, chronic back pain, skin conditions, or existing neuropathies * Patients who cannot understand the use of a patient controlled epidural analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute pain by narcotic use after cesarean section | 0-48 hours after surgery | Directly compare narcotic use in patients who have a TAP block, who have a patient - controlled epidural analgesia, or common care ( neuraxial opioid alone) while in the hospital / acute pain after Cesarean Section Will use morphine equivalents |
| Acute pain by pain scores after cesarean section | 0-48 hours | Directly compare pain scores in patients who have a TAP block, who have a patient - controlled epidural analgesia, or common care ( neuraxial opioid alone) while in the hospital / acute pain after Cesarean Section Will use VAS (0-10), pain at rest, pain with movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Quality in Anesthesia / Maternal Satisfaction | 0-48 hours | Using the validated, Perception of Quality in Anaesthesia (PQA) questionnaire, the patients assessed their overall experience of the cesarean section and post-operative pain management and anesthetic care |
| Pruritus | 0-48 hours | Is a positive to pruritus if the patients answers yes to the question, have you experienced any itching or if a drug was specifically used to treat itching via a review of the MAR |
| Chronic pain by narcotic use | 6 weeks post-partum | Directly compare narcotic use in the three groups at the six week visit, evaluating for chronic pain after Cesarean Section. Will use dose of buprenorphine and/or methadone Will use morphine equivalents |
| Vomiting | 0-48 hours | Is a positive to vomiting if the patients answers yes to the question, have you experienced any vomiting or if a drug was specifically used to treat vomiting via a review of the MAR |
| Chronic pain by pain scores | 6 weeks post-partum | Directly compare pain scores in the three groups at the six week visit, evaluating for chronic pain after Cesarean Section. Will use VAS score (0-10), pain at rest and pain with movement |
| Nausea | 0-48 hours | Is a positive to nausea if the patients answers yes to the question, have you experienced any nausea or if a drug was specifically used to treat nausea via a review of the MAR |
| Respiratory depression | 0-48 hours | Oxygen requirement, narcan use (yes / no), rapid response or code blue called |
Countries
United States
Outcome results
None listed