Pocket Warming of Epidural Medication

NCT02912078 | Completed

• 1 other identifier: 2016H0153
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia.

Conditions

Epidural Anesthesia in Labor and Delivery

Outcome Measures

Primary Outcomes (1)

• Time until pain score less than or equal to 3

  Assess pain level regularly during labor

  duration of labor and delivery

Secondary Outcomes (4)

• Labor analgesia satisfaction

  first hour of epidural administration

• Vital Signs

  during labor and delivery

• Breakthrough pain

  during labor

• Mode of delivery

  Delivery

Study Arms (2)

Pocket-warmed epidural medication

EXPERIMENTAL

This arm will consist of pocket-warmed epidural medications to be administered per standard protocol to patients randomized to this group; this group is the pocket-warming group.

Other: Pocket-warming

Room-temperature epidural medication

ACTIVE COMPARATOR

This arm will consist of room-temperature epidural medications to be administered per standard protocol to patients randomized to this group. This group has no experimental intervention; standard of care labor epidural.

Other: Standard of Care Labor Epidural

Interventions

Pocket-warming OTHER

Pocket-warming of epidural medication

Pocket-warmed epidural medication

Standard of Care Labor Epidural OTHER

Labor epidural medication administered per standard of care; no pocket warming.

Room-temperature epidural medication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a single vertex presentation fetus at term (38-42 weeks)
• Intact fetal membranes or membrane rupture \<6 hours previously
• Request to have an epidural for labor analgesia
• Provide written consent for the study.

You may not qualify if:

• Patients being treated/managed for chronic pain
• Allergies or significant adverse reactions to local anesthetic or opioid medications
• Contraindication to labor epidural placement
• Patients with history of spine abnormalities or spine surgery
• Clinical signs or symptoms of infection
• Baseline temperature \> 37.6 °C
• Non-English speaking
• Prisoners
• Age less than 18 years old

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• John Coffman, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical, Anesthesiology

Model Details: we propose to conduct a prospective, randomized controlled trial to compare the initiation of labor with room temperature epidural medication (pharmacy-prepared 0.125% Bupivacaine with Fentanyl 2mcg/ml - 10mL) to the same epidural medication that has been pocket warmed for a minimum of 1 hour

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: September 23, 2016
• Study Start: September 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)