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

NCT02159807 | Completed Results

• 1 other identifier: GCO 13-0210
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pain control; labor; epidural; pregnant

Outcome Measures

Primary Outcomes (1)

• Maternal Blood Pressure

  Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension

  at 1 hour

Secondary Outcomes (2)

• Fetal Heart Rate at 1 Hour

  at 1 hour

• Mean Change in Visual Analog Scale for Pain

  baseline and 60 minutes

Study Arms (3)

1.25 mg Bupivacaine

ACTIVE COMPARATOR

1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

Drug: Bupivacaine; Drug: Fentanyl

1.66 mg Bupivacaine

ACTIVE COMPARATOR

1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

Drug: Bupivacaine; Drug: Fentanyl

2.5 mg Bupivacaine

ACTIVE COMPARATOR

2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic

Drug: Bupivacaine; Drug: Fentanyl

Interventions

Bupivacaine DRUG

The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.

Also known as: Fentanyl

1.25 mg Bupivacaine; 1.66 mg Bupivacaine; 2.5 mg Bupivacaine

Fentanyl DRUG

20 micrograms routinely administered in combination in the spinal anesthetic

1.25 mg Bupivacaine; 1.66 mg Bupivacaine; 2.5 mg Bupivacaine

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

Roosevelt hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Barbara Orlando
• Organization: Icahn School of Medicine at Mount Sinai

barbara.orlando@mountsinai.org

917-496-7490

Study Officials

• Jonathan Epstein, M.D.

  Mount Sinai Roosevelt Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: April 24, 2015
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)