Comparing two methods of pain relief during labor
Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
This study is testing whether giving pregnant women in labor pain relief through a timed injection of medication works better and uses less medicine than a steady drip of the same medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT03730753 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of programmed intermittent epidural bolus versus continuous infusion for labor analgesia. Pregnant women in labor will be randomly assigned to receive either a programmed bolus of bupivacaine every 45 minutes or a continuous infusion of the medication. Both groups will have the option to use patient-controlled analgesia (PCEA) for additional pain relief as needed. The goal is to determine if the intermittent bolus method can reduce the overall consumption of bupivacaine compared to the continuous infusion method.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older in early labor who consent to epidural analgesia.
Not a fit: Patients with pregnancy-related comorbidities, multiple gestations, or those with a history of chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective pain management during labor with reduced medication use.
How similar studies have performed: Previous studies have shown varying success with different epidural analgesia techniques, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant nulliparous or multiparous woman in labour * Age ≥18 years * Obtained consent for epidural analgesia * ASA classification I-II-III * Early labour (cervical dilation ≤6cm) Exclusion Criteria: * Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus) * Prematurity (\<36 weeks of gestation) * Multiple gestation * Fentanyl allergy or hypersensitivity * Patient unable to understand the PCEA * Fetal breech position * Maternal cardiac pathology and contraindication to Valsalva manoeuvre * Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus * Intrathecal catheter or intravascular catheter * Accidental dural puncture * Patient refusal * Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia
Where this trial is running
Sherbrooke, Quebec
- Chus — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Geneviève Rivard, Dr. — Université de Sherbrooke
- Study coordinator: Isabelle Caron, Dr.
- Email: isabelle.caron4@usherbrooke.ca
- Phone: +1 819 346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.