Impact of Patient Choice for Epidural Potency on Maternal Satisfaction

N/ANot Yet RecruitingNCT07414407

Stanford University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Epidural Analgesia, Obstetric Maternal Satisfaction

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Planned vaginal delivery * Patient requesting epidural labor analgesia * Gestational age \>34 weeks Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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)

Time frame: 24 hours after delivery

Secondary Outcomes

Concordance among four maternal satisfaction instruments

Correlation coefficient between four validated satisfaction instruments : (1) Single-item overall satisfaction (Likert 1-5), (2) Single-item willingness to have the same epidural again (6-point agreement: Disagree very much -\> Agree very much), (3) Self-reported percent satisfaction (0-100%), and (4) Birth Satisfaction Scale-Revised (BSS-R) total score (scored per BSS-R guidelines).

Time frame: 24 hours after delivery

Concordance among intrapartum pain measurement methods

Statistical agreement between intrapartum pain measures: the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain), the 11-point NRS coping ability (0 = totally unable to cope, 10 = totally able to cope), and a target pain measure.

Time frame: During labor, every one hour from epidural insertion until delivery