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

Maternal and Child Health Hospital of Hubei Province

Status and phase: Enrolling; Phase 2

Conditions: Labor Pain; Analgesia

Treatments: Drug: Ropivacaine; Drug: Hydromorphone; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06036797

MCHH_003

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups

Group 1

Experimental group

Description:

Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

Group 2

Experimental group

Description:

Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

Group 3

Experimental group

Description:

Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

Group 4

Active Comparator group

Description:

Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine

Treatment:

Drug: Sufentanil

Drug: Ropivacaine