Predicting Perineal Pain During the Expulsive Phase Under Obstetric Epidural Analgesia

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - Not specified
Sex eligible: Female
Healthy volunteers: Not accepted
Participants: 340 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Insufficient perineal coverage can cause pain as the baby's head emerges, a condition that affects 30% of patients. Currently, there is no consensus on which cold-test site is most predictive of this pain.

Detecting a block that does not extend to the sacral roots is crucial for anticipating the pain experienced during the emergence of the baby's head. Identifying the most predictive testing site would allow the anesthesiologist to anticipate this pain and adjust analgesic management accordingly.

Read the full description

Epidural analgesia (ED) is the gold standard for pain relief during labor. An accurate assessment of its sensory and motor coverage is essential to ensure both effective pain relief and patient safety. Insufficient perineal coverage can cause pain as the baby's head emerges, a condition that affects 30% of patients. Currently, there is no consensus on which cold-test site is most predictive of this pain. Several dermatomal areas can be assessed at the patient's bedside: the outer edge of the foot (S1 root), the posterior aspect of the thigh (S1-S2 roots), and the perianal region (S3-S4-S5 roots). A direct comparison of these three sites, tested on the same patient upon admission for delivery, has not been established.

Detecting a block that does not extend to the sacral roots is crucial for anticipating the pain experienced during the emergence of the baby's head. Identifying the most predictive testing site would allow the anesthesiologist to anticipate this pain and adjust analgesic management accordingly.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Female patients aged ≥ 18 years
Singleton pregnancy ≥ 37 weeks of amenorrhea
Indication for epidural analgesia during spontaneous labor
Cephalic presentation
Informed consent
Proficiency in French

Exclusion Criteria:

Refusal to participate
Contraindications to epidural analgesia
Pre-existing neurological condition
Infection at the puncture site
Uncorrected coagulation disorder
Obstetric emergency requiring immediate delivery
Guardianship, conservatorship, or court-ordered protection

Study population

Pregnant patients from University Hospital of Toulouse

Understand screening

Treatment, groups and participation

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Assignment: Not reported
Masking: Not reported

Pregnant woman with Indication for epidural analgia

Pregnant woman, Singleton pregnancy ≥ 37 weeks of amenorrhea, Indications for epidural analgesia during spontaneous labor, Cephalic presentation

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

diagnostic performance comparison of three sites for testing sensitivity to cold

Time frame: Day 0 (emergence of the fetal head)

Composite criterium: diagnostic performance (sensitivity, specificity, positive and negative predictive values, area under the ROC curve) comparison of three sites for testing sensitivity to cold-the outer edge of the foot, the posterior thigh, and the perianal region-to predict the onset of pain upon the emergence of the fetal head, defined as an intensity of ≥ 4/10 on the numerical scale (NS), in parturients under epidural analgesia.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (0)

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No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor: University Hospital, Toulouse
Study start: 2026-11 Estimated
Primary completion: 2027-05 Estimated
Study completion: 2027-05 Estimated
First posted: Nov 9, 2026 Actual
Last updated: Nov 9, 2026 Actual

Official study contacts

Kaissar SASSI, MD-PHCONTACTsassi.k@chu-toulouse.fr +33 5 61 77 22 33

Official study title

Diagnostic Performance of Sensitive Testing of Sacral Dermatomes for Predicting Perineal Pain During the Expulsive Phase Under Obstetric Epidural Analgesia: A Prospective Diagnostic Study.

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026