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

Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone, After Cesarean Section

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.

Study Overview

• Status: Withdrawn
• Conditions: Caesarean Delivery
• Intervention / Treatment: Drug: Morphine; Drug: TAP Block; Drug: Acetaminophen; Drug: Ropivacaine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAP BLOCK; 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.	Drug: TAP 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; Drug: Acetaminophen; 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
Active Comparator: Common Care; 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.	Drug: Morphine; Drug: Acetaminophen; 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
Active Comparator: Patient Controlled Epidural Analgesia; 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.	Drug: Acetaminophen; 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; Drug: Ropivacaine; The intervention of the Patient Controlled Epidural Analgesia will be compared to the intervention of a TAP block and the intervention of Common Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pain by narcotic use after cesarean section	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	0-48 hours after surgery
Acute pain by pain scores after cesarean section	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	0-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain by narcotic use	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	6 weeks post-partum
Respiratory depression	Oxygen requirement, narcan use (yes / no), rapid response or code blue called	0-48 hours
Perception of Quality in Anesthesia / Maternal Satisfaction	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	0-48 hours
Pruritus	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	0-48 hours
Nausea	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	0-48 hours
Vomiting	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	0-48 hours
Chronic pain by pain scores	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	6 weeks post-partum

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Massachusetts General Hospital; Brigham and Women's Hospital
• Investigators: Principal Investigator: Marnie B Welch, MD, Dartmouth-Hitchcock Medical Center; Study Director: Michaela Farber, MD, Brigham and Women's Hospital; Study Director: Lisa Leffert, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Buprenorphine; Suboxone; Subutex; Buprenex; Caesarean Delivery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Ropivacaine; Morphine
• Other Study ID Numbers: D14074