RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.

November 21, 2019 updated by: University of Florida

A Randomized Clinical Trial to Compare the Addition of Epinephrine (no Epinephrine, 100mcg, and 200mcg) to the Standard Dose of Hyperbaric Bupivacaine 12mg, Fentanyl 20mcg and Morphine 150mcg in Scheduled C-sections.

This is a prospective, randomized, double blind study of 75 patients (n=25 for each group) in which epinephrine (100mcg or 200mcg) or normal saline vehicle is added to intrathecal hyperbaric bupivacaine (0.75% bupivacaine hydrochloride in 8.25% dextrose), fentanyl, and morphine to prolong the duration of the spinal anesthetic in scheduled cesarean deliveries. The primary outcome of duration will be the time to T10 level sensory regression as well as motor level regression that will be graded via the modified Bromage scale.

Repeat cesarean sections, in particular, are associated with increased operative time and thus often performed with a spinal-epidural (CSE) technique. The epidural component is, however, untested and may not provide adequate anesthesia, thus the higher risk of conversion to a general anesthesia. Epinephrine is routinely used to prolong spinal anesthesia. If effective for the duration of a repeat cesarean section it would obviate the additional time and risks of performing the epidural and still avoid sufficient duration to avoid conversion to a general anesthetic.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Spinal anesthesia is the most common type of anesthetic for C-section, but its major limitation is that the duration of the anesthesia may be less than the operative time. Repeat C-section is particularly associated with increased operative time and is often performed under a continuous spinal-epidural (CSE) technique. The epidural component is, however, untested and may not provide adequate anesthesia, thus necessitating the risk general anesthesia. Epinephrine may be used to prolong spinal anesthesia. This study will evaluate the optimal dose of epinephrine as an adjunct to usual spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative free morphine.

Adding epinephrine to hyperbaric bupivacaine helps in prolonging the duration of anesthesia and the quality of analgesia. However, the time to regression of the block effective for surgical anesthesia is not known for a C-section. Better quantification of this factor would help in choosing a spinal technique over a CSE in obstetric patients. This study seeks to quantify the duration of effective spinal anesthesia with the addition of either 100 or 200 mcg of epinephrine to an intrathecal mixture of hyperbaric bupivacaine and narcotics.

With early local anesthetics such as metycaine, nupercaine, or tetracaine, epinephrine was shown to intensify and prolonged their effects. Subsequent studies suggest that subarachnoid anesthesia with a combination of hyperbaric bupivacaine combined with an opioid and an adrenergic drug may be superior to techniques relying solely on local anesthetic drug. However, most of the studies were conducted in an orthopedic population for ambulatory and total joint arthroplasty for elderly patients.

Currently, it is well accepted that the addition of intrathecal narcotics will enhance the quality and duration of a spinal block.

Two investigations sought to determine the ED 95 dose of hyperbaric bupivacaine in combination with fentanyl and morphine to provide surgical anesthesia for operative success for cesarean delivery. Despite differences in spinal technique (sitting vs. lateral) the ED95 dose was 11.2 and 12 respectively. However, the mean duration of surgeries in those studies were significantly less (41 ± 15 and 64 ± 16 min respectively) than the mean duration of an elective C-section in our institution (90 ± 27 min with a 95th percentile of 135 min).

Since 12mg hyperbaric bupivacaine is the upper limit of acceptable doses for an elective C-section this study will evaluate the efficacy of epinephrine to extend the duration of effective surgical anesthesia.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Elective C-section patients
  • ASA physical status class 1-3
  • Age >18 years
  • Height 140-180 cm
  • Singleton pregnancy
  • Gestational age ≥35 weeks

Exclusion Criteria:

  • Age < 18 yo
  • Prisoner status
  • BMI > 45 Laboring patients with epidural going for emergency C-section Opioid abuse in the past 6 months Allergies to any of the adjuncts added to the spinal drug. Ruptured membranes four or more previous cesarean deliveries intrauterine growth retardation, abnormal placentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
normal saline vehicle added to subarachnoid block
Other: normal saline
placebo comparator
Experimental: 100 mcg epinephrine
100 mcg epinephrine added to subarachnoid block
Drug: 100 mcg Epinephrine
This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.
Experimental: 200 mcg epinephrine
200 mcg epinephrine added to subarachnoid block
Drug: 200 mcg Epinephrine
This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T4 sensory level
Time Frame: 15 minutes
Time to T4 sensory level (this will be assessed by pin prick at the anterior axillary line)
15 minutes
T10 sensory regression
Time Frame: 120 minutes
Time to regression to a T10 sensory level (this will be assessed by pinprick at the anterior axillary line)
120 minutes
Analgesia
Time Frame: 120 minutes
Analgesia levels of the patient during the surgery (Pain scores will be measured at the beginning of surgery and during delivery, uterine manipulation, peritoneal suturing and skin closure. 0-10 pan scale)
120 minutes
Epidural dosing
Time Frame: 120 minutes
Time elapsed after the spinal dose to the start of epidural dosing (this will be be assessed by review of the anesthesia record as the first recorded supplemental does of local anesthetic)
120 minutes
Satisfaction
Time Frame: 120 minutes and up to 24 hours after surgery
Satisfaction levels of the patient during the surgery. (Maternal satisfaction will be quantified using a VAS score (0=no satisfaction and 100=full satisfaction) at the end of surgery and during a postoperative patient examination. )
120 minutes and up to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Paul Mongan, MD, UF COMJ Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201702657 - A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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