Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

Nanjing Medical University

Status: Completed

Conditions: Cesarean Section; Restless Leg Syndrome

Treatments: Procedure: Spinal anesthesia; Procedure: Epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00872248

NJFY09102M112

NMU-200903-MZ005

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups

1

Experimental group

Description:

Parturients received spinal anesthesia

Treatment:

Procedure: Spinal anesthesia

2

Active Comparator group

Description:

Parturients received epidural anesthesia

Treatment:

Procedure: Epidural anesthesia