Impact of Patient Choice for Epidural Potency on Maternal Satisfaction

NCT07414407 | Not Yet Recruiting

• 1 other identifier: IRB-84223
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will compare two different approaches to epidural analgesia during labor to see which approach leads to higher patient satisfaction after delivery. Primary aim: determine whether one approach produces greater postpartum maternal satisfaction. Secondary aims: compare pain control and side effects. Participants are people in labor who receive epidural analgesia. They will receive routine clinical epidural care and complete brief, in-hospital questionnaires about pain and satisfaction. All care is provided by the clinical team and safety practices remain unchanged.

Conditions

Epidural Analgesia, Obstetric; Maternal Satisfaction

Outcome Measures

Primary Outcomes (1)

• Maternal satisfaction with epidural analgesia

  Participant rating of overall satisfaction with pain care on a 5-point Likert scale (Describe your overall satisfaction with your epidural labor pain relief (Likert 1: very dissatisfied; 2: relatively dissatisfied; 3: fair; 4: relatively satisfied; 5: very satisfied)

  24 hours after delivery

Secondary Outcomes (2)

• Concordance among four maternal satisfaction instruments

  24 hours after delivery

• Concordance among intrapartum pain measurement methods

  During labor, every one hour from epidural insertion until delivery

Study Arms (2)

Choice

EXPERIMENTAL

Participants will select a preferred epidural regimen, receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction.

Procedure: Patient-selected epidural management

No-choice

ACTIVE COMPARATOR

Participants will receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction.

Procedure: Standard epidural management

Interventions

Patient-selected epidural management PROCEDURE

Choice of epidural regimen

Choice

Standard epidural management PROCEDURE

Hospital's usual epidural regimen

No-choice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Planned vaginal delivery
• Patient requesting epidural labor analgesia
• Gestational age \>34 weeks

You may not qualify if:

• Any contraindication to neuraxial block
• History of chronic pain, anxiety or depression
• Intolerance or allergy to local anesthetic or opioids
• Cesarean delivery within 2 hours of epidural initiation

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Central Study Contacts

Study Team

CONTACT

(650) 723-5403; brendan.carvalho@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)