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| ID | Type | Description | Link |
|---|---|---|---|
| JQX12009 | Other Grant/Funding Number | Nanjing Municipal Bureau of Health |
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It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sole local anesthetic | Experimental | Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently |
|
| Opioid plus local anesthetic | Active Comparator | Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sole local anesthetic | Drug | 0.125% ropivacaine 10-15 ml every 1h during labor delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scorings | Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus | Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to latent phase | Record the time duration | From the beginning of regular contraction of uterus to the dilation of cervical 4cm |
| Time of active phase | Record the time duration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26512604 | Derived | Wang X, Xu S, Qin X, Li X, Feng SW, Liu Y, Wang W, Guo X, Shen R, Shen X, Wang F. Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia. Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| D000701 | Analgesics, Opioid |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Sufentanil (Opioid plus local anesthetic) | Drug | Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery |
|
|
| Ropivacaine | Drug |
|
| Dizziness | Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Nausea | Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Vomiting | Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Drowsiness | Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Sedation | Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Respiratory depression | Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Psychological effects | Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Myoclonus | This describes muscle rigidity and abnormal movement of the limbs and muscles. Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Maternal heart rate | Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Miosis | Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. | From post-randomization to post-delivery day 3 |
| Cesarean section | Record the incidence of Cesarean section after completion of the labor delivery. | The time at the end of the labor delivery |
| From the cervix 4cm to the dilation of cervical 10cm |
| Overall satisfaction of analgesia | Assess the analgesia satisfaction after the completion of the labor delivery | At the time of the end of the labor delivery |
| Oxytocin usage | Record the total usage of oxytocin after completion of the labor delivery | At the time of the end of the labor |
| Neonatal Apgar score | At the time of the baby was born, 1min, 5min, 10min and 20min |
| Instrumental delivery | Record the incidence of instrumental delivery after completion of the labor delivery. | At the time of the end of the labor |
| Umbilical gas analysis | At the time of the fetus was delivery |
| D000588 |
| Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000777 | Anesthetics |