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

Phase 2

Recruiting

• Conditions: Labor Pain; Analgesia
• Interventions: Drug: Sufentanil; Drug: Hydromorphone; Drug: Ropivacaine

• Registration Number: NCT06036797
• Lead Sponsor: Maternal and Child Health Hospital of Hubei Province

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-09-17
• Status Verified: 2023-10
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4	Ropivacaine	Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
Group 4	Sufentanil	Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
Group 2	Hydromorphone	Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
Group 1	Ropivacaine	Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
Group 2	Ropivacaine	Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
Group 1	Hydromorphone	Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
Group 3	Hydromorphone	Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
Group 3	Ropivacaine	Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale(VAS)	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 Outcome Measures

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

Trial Locations

Locations (1)

Maternal and Child Health Hospital of Hubei Province; 🇨🇳 Wuhan, Hubei, China