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

NCT02091297 | Withdrawn

• 1 other identifier: D14074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Caesarean Delivery

Keywords

Buprenorphine; Suboxone; Subutex; Buprenex; Caesarean Delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Chronic pain by narcotic use

  6 weeks post-partum

• Respiratory depression

  0-48 hours

• Perception of Quality in Anesthesia / Maternal Satisfaction

  0-48 hours

• Pruritus

  0-48 hours

• Nausea

  0-48 hours

Study Arms (3)

TAP BLOCK

ACTIVE COMPARATOR

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; Drug: Acetaminophen

Common Care

ACTIVE COMPARATOR

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; Drug: Morphine

Patient Controlled Epidural Analgesia

ACTIVE COMPARATOR

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; Drug: Acetaminophen

Interventions

TAP Block DRUG

This intervention of a TAP block will be compared to the intervention of Common Care and to the intervention of Patient Controlled Epidural Analgesia

TAP BLOCK

Ropivacaine DRUG

The intervention of the Patient Controlled Epidural Analgesia will be compared to the intervention of a TAP block and the intervention of Common Care

Patient Controlled Epidural Analgesia

Acetaminophen DRUG

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

Common Care; Patient Controlled Epidural Analgesia; TAP BLOCK

Morphine DRUG

Common Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Ropivacaine; Acetaminophen; Morphine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Marnie B Welch, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Michaela Farber, MD

  Brigham and Women's Hospital

  STUDY DIRECTOR

• Lisa Leffert, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 19, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

US (3)