Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia

The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.

Study Overview

• Status: Terminated
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Tetracaine; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center- OB Anesthesia dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• early labor (>=2cm but =<6cm cervical dilation)
• at least 12 years of age
• have an assigned ASA physical status 1 or 2
• singleton pregnancy

Exclusion Criteria:

• contraindications to neuraxial anesthesia
• with allergies to drugs used in the study
• have an assigned ASA status 3 or 4
• advanced labor (> 6cm cervical dilation)
• less than 12 years of age
• Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tetracaine 2mg	Drug: Tetracaine; Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
Active Comparator: Bupivacaine 2 mg	Drug: Bupivacaine; Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Analgesic Duration	duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete	1-2 hrs

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Peter H. Pan, MD, WFUHS

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 12, 2011
• Study Completion (Actual): December 12, 2011

Study Registration Dates

• First Submitted: October 30, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: labor pain; labor analgesia; combined spinal epidural labor analgesia; CSE analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Tetracaine
• Other Study ID Numbers: IRB 9824

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No