Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control

Conditions
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Pain

Intervention / Treatment
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* Drug: Sole local anesthetic
* Drug: Sufentanil (Opioid plus local anesthetic)
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparas Request epidural analgesia Chinese Exclusion Criteria: Allergic to opioid or local anesthetics Fail to perform epidural puncture and catheterization Organ dysfunction Contraindications for epidural anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sole local anesthetic<br>Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently | Drug: Sole local anesthetic<br>* 0.125% ropivacaine 10-15 ml every 1h during labor delivery<br>* Other names: Naropin;Drug: Ropivacaine<br> <br> |
| Active Comparator: Opioid plus local anesthetic<br>Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently | Drug: Sufentanil (Opioid plus local anesthetic)<br>* Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery<br>* Other names: Naropin;Drug: Ropivacaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Local anesthetic, Labor delivery, Safety