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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial

Conditions
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Analgesia, Labor Pain

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Sufentanil
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine | Drug: Hydromorphone<br>* 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<br>Drug: Ropivacaine<br>* 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms<br>|
| Experimental: Group 2<br>Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine | Drug: Hydromorphone<br>* 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<br>Drug: Ropivacaine<br>* 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms<br>|
| Experimental: Group 3<br>Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine | Drug: Hydromorphone<br>* 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<br>Drug: Ropivacaine<br>* 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms<br>|
| Active Comparator: Group 4<br>Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine | Drug: Sufentanil<br>* For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil<br>Drug: Ropivacaine<br>* 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 minutes-1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 minutes-1.5 hours | 
| Mean arterial pressure(MAP) | 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). | 30 minutes-1.5 hours | 
| Pulse oxygen saturation | 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). | 30 minutes-1.5 hours | 
| Duration of analgesia | Defined as the time from labor analgesia to delivery of the fetus. | 30 minutes-1.5 hours | 
| The number of compressions | The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus. | 30 minutes-1.5 hours | 
| Adverse reactions | The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions). | 30 minutes-1.5 hours | 
| The Apgar scores | The Apgar scores of 1 minute and 5 minutes after birth will be recorded. | 1 minute and 5 minutes after birth |