Clinical trial NCT02091297: Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone
Official title: Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone, After Cesarean Section
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caesarean Delivery
Keywords: Buprenorphine
Suboxone
Subutex
Buprenex
Caesarean Delivery
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Brigham and Women's Hospital
First posted: 2014-03-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute pain by narcotic use after cesarean section
timeFrame: 0-48 hours after surgery
measure: Acute pain by pain scores after cesarean section
timeFrame: 0-48 hours
Secondary outcomes:
measure: Chronic pain by narcotic use
timeFrame: 6 weeks post-partum
measure: Respiratory depression
timeFrame: 0-48 hours
measure: Perception of Quality in Anesthesia / Maternal Satisfaction
timeFrame: 0-48 hours
measure: Pruritus
timeFrame: 0-48 hours
measure: Nausea
timeFrame: 0-48 hours
measure: Vomiting
timeFrame: 0-48 hours
measure: Chronic pain by pain scores
timeFrame: 6 weeks post-partum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Marnie B Welch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Michaela Farber, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Lisa Leffert, MD
role: STUDY_DIRECTOR
References: