Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia

Maternal and Child Health Hospital of Hubei Province

Status and phase: Completed; Phase 2

Conditions: Labor Pain; Analgesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05901441

MCHH_002

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: 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.

Enrollment: 240 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

poor respiratory functions severe cardiovascular diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups

H1 group

Experimental group

Description:

H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

H2 group

Experimental group

Description:

H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

H3 group

Experimental group

Description:

H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Hydromorphone

SF group

Active Comparator group

Description:

SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine

Treatment:

Drug: Ropivacaine

Drug: Sufentanil