Analgesia, Labor Pain
Conditions
Brief 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.
Interventions
DRUGHydromorphone
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
DRUGSufentanil
For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil
DRUGRopivacaine
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Sponsors
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale(VAS) | 30 minutes-1 hour | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure(MAP) | 30 minutes-1.5 hours | MAP 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). |
| Pulse oxygen saturation | 30 minutes-1.5 hours | Pulse oxygen saturation 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). |
| Duration of analgesia | 30 minutes-1.5 hours | Defined as the time from labor analgesia to delivery of the fetus. |
| Heart rate(HR) | 30 minutes-1.5 hours | 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). |
| Adverse reactions | 30 minutes-1.5 hours | The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions). |
| The Apgar scores | 1 minute and 5 minutes after birth | The Apgar scores of 1 minute and 5 minutes after birth will be recorded. |
| The number of compressions | 30 minutes-1.5 hours | The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus. |
Countries
China
Contacts
Primary ContactNa Li, MD
Outcome results
None listed