A Double-Blind, Randomized, Controlled Study of the Efficacy and Safety of Continuous Low-Dose Naloxone Administration for Opioid-Induced Pruritus During Labor Epidural Analgesia

A Double-Blind, Randomized, Controlled Study of the Efficacy and Safety of Continuous Low-Dose Naloxone Administration for Opioid-Induced Pruritus During Labor Epidural Analgesia - NAL-LA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240551

Enrollment

Registered

2024-12-13

Start date

2025-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Induced Pruritus During Labor Epidural Analgesia

Interventions

-The principal (sub) investigators will administer the study drug (naloxone or placebo) according to the allocation results. -The study drug administration will begin when fentanyl and local anesthet

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Parturient who are scheduled to have a labor analgesia (those who wish to have a labor analgesia and whose doctor has determined that labor analgesia is indicated, or those who are medically indicated for labor analgesia). 2. Parturient with a gestational age of 32 weeks or more. 3. Parturient who are capable of receiving epidural analgesia (no coagulopathy, spinal disease, neurological disease, or other factors that preclude epidural analgesia). 4. Parturient who are 20 years of age or older at the time of consent. 5. Parturient who have obtained consent from the parturient themselves to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1. Parturient with pruritus before the start of epidural analgesia 2. Parturient whose cervical dilation is up to 8 cm at the time of examination before the start of epidural analgesia. 3. Parturient with severe mental disorders. 4. Parturient with a history of severe hypersensitivity to naloxone 5. Parturient with respiratory depression due to non-narcotic CNS depressants such as barbiturates, or pathological causes. 6. Parturient who are deemed inappropriate to participate in this study by the Principal Investigator.

Design outcomes

Primary

Measure	Time frame
Percentage of Pruritus	—

Secondary

Measure	Time frame
1.Degree of pruritus (VRS) 2.Nausea and vomiting (PONV impact scale) 3.Level of pain (NRS) 4.Degree of lower extremity motor nerve blockade(Bromage scale) 5.Drug usage for epidural analgesia 6.1-minute and 5-minute Apgar score of the child 7.initial resuscitation of a child 8.umbilical artery blood pH 9.Percentage of adverse events	—

Contacts

Public ContactSatoshi Toyama

Institute of Science Tokyo Hospital

Toyama.mane@tmd.ac.jp+81-3-5803-5325

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026