NCT06036797|UnknownPhase 2
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Sponsor study identifier
interventional
240
1 country
1
Study Start
September 17, 2023
Actual (reported)Primary Completion
October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2023
Actual (reported)September 14, 2023
Actual (reported)September 17, 2023
Actual (reported)October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
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
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000, China
Na Li, MD
Maternal and Child Health Hospital of Hubei Province
First Submitted
September 7, 2023
First Posted
September 14, 2023
Study Start
September 17, 2023
Actual (reported)Primary Completion
October 17, 2023
Estimated (date passed)Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.
Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 26, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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