Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02091297
Recruitment Status : Withdrawn (two other institutions that were in the center thought they weren't going to be able to recruit enough patients)
First Posted : March 19, 2014
Last Update Posted : August 5, 2016
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Caesarean Delivery Drug: TAP Block Drug: Ropivacaine Drug: Acetaminophen Drug: Morphine Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone, After Cesarean Section
Study Start Date : April 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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: Morphine
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: 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

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Acute pain by narcotic use after cesarean section [ Time Frame: 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


  2. Acute pain by pain scores after cesarean section [ Time Frame: 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 Outcome Measures :
  1. Chronic pain by narcotic use [ Time Frame: 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


  2. Respiratory depression [ Time Frame: 0-48 hours ]
    Oxygen requirement, narcan use (yes / no), rapid response or code blue called

  3. Perception of Quality in Anesthesia / Maternal Satisfaction [ Time Frame: 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

  4. Pruritus [ Time Frame: 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

  5. Nausea [ Time Frame: 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

  6. Vomiting [ Time Frame: 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

  7. Chronic pain by pain scores [ Time Frame: 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091297


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02091297    
Other Study ID Numbers: D14074
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Dartmouth-Hitchcock Medical Center:
Buprenorphine
Suboxone
Subutex
Buprenex
Caesarean Delivery
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Analgesics, Non-Narcotic
Antipyretics