Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

NCT06036797 | Unknown Phase 2

• 1 other identifier: MCHH_003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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 : 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.

Conditions

Analgesia; Labor Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale(VAS)

  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).

  30 minutes-1 hour

Secondary Outcomes (7)

• Heart rate(HR)

  30 minutes-1.5 hours

• Mean arterial pressure(MAP)

  30 minutes-1.5 hours

• Pulse oxygen saturation

  30 minutes-1.5 hours

• Duration of analgesia

  30 minutes-1.5 hours

• The number of compressions

  30 minutes-1.5 hours

Study Arms (4)

Group 1

EXPERIMENTAL

Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

Group 2

EXPERIMENTAL

Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

Group 3

EXPERIMENTAL

Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

Group 4

ACTIVE COMPARATOR

Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine

Drug: Sufentanil; Drug: Ropivacaine

Interventions

Hydromorphone DRUG

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

Group 1; Group 2; Group 3

Sufentanil DRUG

For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil

Group 4

Ropivacaine DRUG

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

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status II
• a single fetus
• competent to provide informed consent

You may not qualify if:

• severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia
• severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
• placenta previa

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Agnosia; Labor Pain

Interventions

Hydromorphone; Sufentanil; Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Li, MD

CONTACT

+862763490107; lina@hbfy.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 17, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)