drugset / Trial / NCT06036797

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

NCT06036797

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-09-17
Primary completion
2023-10-17
Completion
2023-10-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 15 ug/ml Other
Subject Hydromorphone Other / unclassified 17.5 ug/ml Other
Subject Hydromorphone Other / unclassified 20 ug/ml Other
Comparator Sufentanil Other / unclassified 0.4 ug/ml Other
Background Ropivacaine Other / unclassified 0.08 % Other

Indications

No indication recorded.