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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036797
• Other study ID #: MCHH_003
• Status: Recruiting
• Phase: Phase 2
• Start date: September 17, 2023
• Est. completion date: October 17, 2023

Study information

• Verified date: October 2023
• Source: Maternal and Child Health Hospital of Hubei Province
• Contact: Na Li, MD
• Phone: +862763490107
• Email: lina[@]hbfy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Labor Pain

Intervention

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
• 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

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Hubei Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Duration of analgesia	Defined as the time from labor analgesia to delivery of the fetus.	30 minutes-1.5 hours
Secondary	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
Secondary	Adverse reactions	The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).	30 minutes-1.5 hours
Secondary	The Apgar scores	The Apgar scores of 1 minute and 5 minutes after birth will be recorded.	1 minute and 5 minutes after birth