Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
- Conditions
- AnalgesiaLabor Pain
- Interventions
- Registration Number
- NCT05901441
- Lead Sponsor
- Maternal and Child Health Hospital of Hubei Province
- 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: 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent
poor respiratory functions severe cardiovascular diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H1 group Hydromorphone H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine H2 group Hydromorphone H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine H3 group Ropivacaine H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine H2 group Ropivacaine H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine H1 group Ropivacaine H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine H3 group Hydromorphone H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine SF group Sufentanil SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine SF group Ropivacaine SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
Duration of analgesia 30 minutes-1.5 hours Defined as the time from labor analgesia to delivery of the fetus.
The Apgar scores 30 minutes-1.5 hours The Apgar scores of 1 and 5 minutes after birth will be recorded.
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).
Adverse reactions 30 minutes-1.5 hours The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).
Trial Locations
- Locations (1)
Maternal and Child Health Hospital of Hubei Province
🇨🇳Wuhan, Hubei, China