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

Maternal and Child Health Hospital of Hubei Province240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Analgesia Labor Pain

Interventions

HydromorphoneDRUG

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

SufentanilDRUG

For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil

RopivacaineDRUG

0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 30 minutes-1 hour

Secondary Outcomes

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).