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

Caesarean Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02091297
• Other study ID #: D14074
• Status: Withdrawn
• Phase: N/A
• First received: March 10, 2014
• Last updated: August 4, 2016
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caesarean Delivery

Intervention

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
• 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
• 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
• Morphine

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Respiratory depression	Oxygen requirement, narcan use (yes / no), rapid response or code blue called	0-48 hours	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No