Skip to main content
OpenTrials
Completed

NCT Number: NCT05901441

Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.

Participants will be randomly allocated to four groups: H1 group,H2 group,H3 group and SF group.For those in H1 group: they will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H3 group: they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in SF group: they will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.

The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Analgesia Agnosia Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent

Exclusion criteria

poor respiratory functions severe cardiovascular diseases

Treatment and study plan

Hydromorphone

Drug

For those in H1 group: they will be administered with15 ug/ml hydromorphone, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone , For those in H3 group: they will be administered with 20 ug/ml hydromorphone

Sufentanil

Drug

For those in SF group: they will be administered with 40 ug/ml sufentanil

Ropivacaine

Drug

0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms

Primary outcomes

  1. Visual Analogue Scale(VAS)

    Time frame: 30 minutes-1 hour

    VAS will be monitored and recorded at 6 time points, including the time of entering the operating room(Time 0), when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), when the first dose is given for 30 minutes(Time 3), 30 minutes after delivery (Time 4), and 60 minutes after delivery (Time 5). The VAS consists of a 10 cm line,with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).

Secondary outcomes

  1. Heart rate(HR)

    Time frame: 30 minutes-1.5 hours

    HR will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

  2. Mean arterial pressure(MAP)

    Time frame: 30 minutes-1.5 hours

    MAP will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

  3. Pulse oxygen saturation

    Time frame: 30 minutes-1.5 hours

    Pulse oxygen saturation will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

  4. Duration of analgesia

    Time frame: 30 minutes-1.5 hours

    Defined as the time from labor analgesia to delivery of the fetus.

  5. The number of compressions

    Time frame: 30 minutes-1.5 hours

    The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.

  6. Adverse reactions

    Time frame: 30 minutes-1.5 hours

    The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).

  7. The Apgar scores

    Time frame: 30 minutes-1.5 hours

    The Apgar scores of 1 and 5 minutes after birth will be recorded.

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.