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

Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Labor Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Hydromorphone; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Na Li, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Maternal and Child Health Hospital of Hubei Province
      • Contact: Na Li, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms; Drug: 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
Experimental: Group 2; Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms; Drug: 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
Experimental: Group 3; Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms; Drug: 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
Active Comparator: Group 4; Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine	Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms; Drug: Sufentanil; For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate(HR)	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).	30 minutes-1.5 hours
Mean arterial pressure(MAP)	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).	30 minutes-1.5 hours
Pulse oxygen saturation	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).	30 minutes-1.5 hours
Duration of analgesia	Defined as the time from labor analgesia to delivery of the fetus.	30 minutes-1.5 hours
The number of compressions	The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.	30 minutes-1.5 hours
Adverse reactions	The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).	30 minutes-1.5 hours
The Apgar scores	The Apgar scores of 1 minute and 5 minutes after birth will be recorded.	1 minute and 5 minutes after birth

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2023
• Primary Completion (Estimated): October 17, 2023
• Study Completion (Estimated): October 17, 2023

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Sufentanil; Hydromorphone
• Other Study ID Numbers: MCHH_003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No