Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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