Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

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.

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Detailed Description

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Conditions

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Cesarean Section Restless Leg Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Parturients received spinal anesthesia

Group Type EXPERIMENTAL

Spinal anesthesia

Intervention Type PROCEDURE

Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg

2

Parturients received epidural anesthesia

Group Type ACTIVE_COMPARATOR

Epidural anesthesia

Intervention Type PROCEDURE

Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg

Interventions

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Spinal anesthesia

Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg

Intervention Type PROCEDURE

Epidural anesthesia

Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg

Intervention Type PROCEDURE

Other Intervention Names

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Intrathecal anesthesia Extradural anesthesia

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No