Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone

Dartmouth Health

Status: Withdrawn

Conditions: Caesarean Delivery

Treatments: Drug: Morphine; Drug: Acetaminophen; Drug: TAP Block; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02091297

D14074

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 3 patient groups

TAP BLOCK

Active Comparator group

Description:

One unique regional technique for lower abdominal surgery, that has been shown effective for Cesarean Section in particular, is the transversus abdominis plane (TAP) block, which blocks T6-L1 sensory nerve branches and provides anesthesia to the anterior abdominal wall. The TAP block has been recommended and shown in case reports, but not clinically studied with trials, for patients on methadone or buprenorphine, to improve post-operative pain control. A long active local anesthetic, called ropivacaine, will be used to provide this anesthesia.

Treatment:

Drug: Acetaminophen

Drug: TAP Block

Common Care

Active Comparator group

Description:

Common care refers to the common way pain is treated after Cesarean Section: a long-acting spinal or epidural opioid such as morphine, plus oral and IV opioids and non-narcotic adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen. Due to the potential issues such as ineffectiveness and fear of respiratory depression, increasing the dosing of these opioids may not be ideal.

Treatment:

Drug: Acetaminophen

Drug: Morphine

Patient Controlled Epidural Analgesia

Active Comparator group

Description:

For post-Cesarean analgesia, another regional technique that has been employed for superior pain control is continued epidural analgesia with local anesthesia and an opioid, either in addition or instead of long acting neuraxial opioids (Cohen). One study revealed equal analgesic efficiency, higher patient satisfaction scores, and less side effects with patient controlled epidural ropivacaine compared to epidural morphine (Chen). This is an especially attractive option for opioid dependent patients, but like the TAP block, has been not studied whether or not it lessens acute or chronic postoperative cesarean section, in the setting or in the absence of neuraxial opioids.

Treatment:

Drug: Acetaminophen

Drug: Ropivacaine