Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

Study Overview
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Brief Summary
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The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting approximately 10% of the population. Different literature had different views on the association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some reported that spinal anesthesia induced postoperative restless leg syndrome, but other studies showed that spinal and general anesthesia all two did not cause restless leg syndrome. A potential difference amongst these studies is that a big difference exists in surgical types. The investigators proposed that different types of surgery performed undergoing various anesthesia, and that there is a big difference in original pathophysiological condition. Therefore, the investigators hypothesized that pregnant women who have special physical states would have had an association between neuraxial anesthesia and restless leg syndrome in such patients who received selective cesarean section undergoing spinal or epidural anesthesia.

Official Title
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Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery

Conditions
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Cesarean Section, Restless Leg Syndrome

Intervention / Treatment
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* Procedure: Spinal anesthesia
* Procedure: Epidural anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnancy Selective cesarean Gestational age >= 37 weeks Chinese Exclusion Criteria: Allergic to local anesthetics Allergic to opioids History of psychosis Cognition malfunction Any organic diseases Original lower extremity dyskinesia and paraesthesia Chronic pain Difficult in sleep Drug and alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Parturients received spinal anesthesia | Procedure: Spinal anesthesia<br>* Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg<br>* Other names: Intrathecal anesthesia;|
| Active Comparator: 2<br>Parturients received epidural anesthesia | Procedure: Epidural anesthesia<br>* Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg<br>* Other names: Extradural anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of restless leg syndrome |  | One day to one week after completion of cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative anesthetic effectiveness | The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means | From the beginning of anesthesia (0 min) to completion of cesarean (45 min) | 
| Postoperative analgesic effectiveness | This will be assessed with visual analog scale (VAS) of pain in a 0 to 10cm scoring bar | From the initiation of analgesia (0 min) to 48 h after cesarean | 
| Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity |  | From the completion of cesarean (1 day) to one week follow-up | 
| Psychological state | This will be assessed with self anxiety and depression scales | From one day to one week follow-up after cesarean | 
| Infant weight |  | Three min after cesarean section | 
| One-min Apgar score |  | One min after cesarean section | 
| Five-min Apgar score |  | Five min after cesarean section | 
| Intraoperative vital signs |  | From the beginning of cesarean (0 min) to completion of operation (45 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block