Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

NCT05901441 | Completed Phase 2

• 1 other identifier: MCHH_002
• 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: 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.

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)

H1 group

EXPERIMENTAL

H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

H2 group

EXPERIMENTAL

H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

H3 group

EXPERIMENTAL

H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine

Drug: Hydromorphone; Drug: Ropivacaine

SF group

ACTIVE COMPARATOR

SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine

Drug: Sufentanil; Drug: Ropivacaine

Interventions

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

H1 group; H2 group; H3 group

Sufentanil DRUG

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

SF group

Ropivacaine DRUG

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

H1 group; H2 group; H3 group; SF group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• poor respiratory functions severe cardiovascular diseases

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

Location

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

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: June 4, 2023
• First Posted: June 13, 2023
• Study Start: June 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

CN (1)