Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

Analgesia Clinical Trial

Official title:

Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901441
• Other study ID #: MCHH_002
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Maternal and Child Health Hospital of Hubei Province
• Contact: n/a
• 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: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

poor respiratory functions severe cardiovascular diseases

Related Conditions & MeSH terms

• Analgesia
• Labor Pain

Intervention

Drug:
• Hydromorphone
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
• Sufentanil
For those in SF group: they will be administered with 40 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 and 5 minutes after birth will be recorded.	30 minutes-1.5 hours