Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

Randomized Double-blinded Study Designed to Optimize the Dose of Bupivacaine in Combined Spinal Epidurals to Reduce the Incidence of Fetal Bradycardia and Maternal Hypotension

The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Bupivacaine; Drug: Fentanyl

Detailed Description

A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Roosevelt hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
• between 37 and 42 weeks gestational age
• maternal age of 18 years or greater

Exclusion Criteria:

• Parturients with pre-eclampsia
• History of pregnancy induced hypertension
• Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
• Patients with non reassuring fetal heart rate tracings prior to placement of the CSE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.25 mg Bupivacaine; 1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic	Drug: Bupivacaine; The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.; Other Names: Fentanyl; Drug: Fentanyl; 20 micrograms routinely administered in combination in the spinal anesthetic
Active Comparator: 1.66 mg Bupivacaine; 1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic	Drug: Bupivacaine; The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.; Other Names: Fentanyl; Drug: Fentanyl; 20 micrograms routinely administered in combination in the spinal anesthetic
Active Comparator: 2.5 mg Bupivacaine; 2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic	Drug: Bupivacaine; The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.; Other Names: Fentanyl; Drug: Fentanyl; 20 micrograms routinely administered in combination in the spinal anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Blood Pressure	Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension	at 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Heart Rate at 1 Hour	Baby's heart rate recorded with the external monitor that is placed on patient's belly, for a duration of 60 minutes after the placement of the combined spinal epidural.	at 1 hour
Mean Change in Visual Analog Scale for Pain	Mean change of her pain relief from the spinal epidural 60 minutes after she received it, using a VAS, scored from 0 to 10, with higher score indicating more pain.	baseline and 60 minutes

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Jonathan Epstein, M.D., Mount Sinai Roosevelt Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2015
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): December 29, 2017

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pregnant; epidural; labor; Pain control
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: GCO 13-0210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO