Labor Pain and to Reduce PainPhase 4EpiVolNCT07684365
Does the Volume of Medication Affect the Success of Labor Epidural Analgesia
A Phase 4 study testing administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes in people with Labor Pain and to Reduce Pain, run by Beth Israel Deaconess Medical Center.
Trial summary
The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain and to Reduce Pain
- What is being tested?
- administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years of age or older
- Gestational age of 36 weeks or greater
- American Society of Anesthesiology physical status 2
- Induction of labor or early labor (cervical dilation < 6cm)
- Singleton gestation
- Vertex presentation
Who cannot join
- Preeclampsia
- Receiving magnesium sulfate
- Having received narcotics within 4 hours
- Multiple gestation
- Major fetal anomalies or demise
- Previous spine surgery
- Known major spine pathology
- Substance use disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Injected Volume on Programmed Intermittent Epidural Bolus Analgesia
The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.
Read the detailed description
This is a randomized, single blinded trial comparing epidural pain relief for labor when medications are delivered in one of two volumes/concentrations. Patients in each arm of the study will receive the same dose of medication, but one will be half as concentrated and twice the volume. The outcome will be the number of supplemental doses of medication that patients receive during labor via their patient-controlled analgesia button.
- Conditions
- Labor Pain and to Reduce Pain
- Being tested
- administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes
- Keywords
- epidural analgesia, Obstetric anesthesia, bupivacaine, fentanyl, programmed intermittent epidural bolus, labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutesDrug
Dose of medication delivered using a programmed intermittent epidural bolus
| Study group | Role | What they receive |
|---|---|---|
| High volume low concentration | Active comparator | combination product: 0.0625% bupivacaine with 2 mcg fentanyl delivered in 12 ml bolused every 40 minutes Receives: Drug: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes |
| Low concentration high volume | Experimental | combination product: 0.125% bupivacaine with 4 mcg fentanyl delivered in 6 ml bolused every 40 minutes Receives: Drug: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient controlled boluses received
The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief
Measured: The duration of labor until delivery of the neonate
Secondary outcomes (2)
Patient controlled boluses requests
The number of patient controlled boluses requested by pressing the PCA button for additional pain relief
Measured: The duration of labor until delivery of the neonate
Physician administered epidural bolus
The number of times that a physician supplies additional medication for the control of pain
Measured: The duration of labor until delivery of the neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Pain and to Reduce PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- Philip Hess, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684365
- Sponsor's protocol ID
- 2025P000941
- Acronym
- EpiVol
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No