Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
NCT ID: NCT06036797
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2023-09-17
2023-10-17
Brief Summary
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Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
Hydromorphone
For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone
Ropivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Group 2
Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
Hydromorphone
For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone
Ropivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Group 3
Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
Hydromorphone
For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone
Ropivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Group 4
Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
Sufentanil
For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil
Ropivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Interventions
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Hydromorphone
For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone
Sufentanil
For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil
Ropivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Eligibility Criteria
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Inclusion Criteria
* a single fetus
* competent to provide informed consent
Exclusion Criteria
* severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
* placenta previa
20 Years
40 Years
FEMALE
No
Sponsors
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Maternal and Child Health Hospital of Hubei Province
OTHER
Responsible Party
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Li Na
Deputy Chief Physician
Principal Investigators
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Na Li, MD
Role: PRINCIPAL_INVESTIGATOR
Maternal and Child Health Hospital of Hubei Province
Locations
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Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MCHH_003
Identifier Type: -
Identifier Source: org_study_id
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