Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

NCT01005459 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB 9824
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

labor pain; combined spinal epidural labor analgesia; CSE analgesia; labor analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tetracaine 2mg

ACTIVE COMPARATOR

Drug: Tetracaine

Bupivacaine 2 mg

ACTIVE COMPARATOR

Drug: Bupivacaine

Interventions

Tetracaine DRUG

Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.

tetracaine 2mg

Bupivacaine DRUG

Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Bupivacaine 2 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Forsyth Medical Center- OB Anesthesia dept

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Tetracaine; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Peter H. Pan MD, MSEE
• Organization: Wake Forest School of Medicine-Anesthesiology

ppan@wakehealth.edu

336-718-8278

Study Officials

• Peter H. Pan, MD

  WFUHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: August 1, 2009
• Primary Completion: December 12, 2011
• Study Completion: December 12, 2011
• Last Updated: November 8, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-06

Locations

US (1)