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Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00872248
First received: March 30, 2009
Last updated: July 26, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Cesarean Section
Restless Leg Syndrome
 Procedure: Spinal anesthesia
Procedure: Epidural anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Occurrence of restless leg syndrome [ Time Frame: One day to one week after completion of cesarean ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraoperative anesthetic effectiveness [ Time Frame: From the beginning of anesthesia (0 min) to completion of cesarean (45 min) ] [ Designated as safety issue: Yes ]
    The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means

  • Postoperative analgesic effectiveness [ Time Frame: From the initiation of analgesia (0 min) to 48 h after cesarean ] [ Designated as safety issue: Yes ]
    This will be assessed with visual analog scale (VAS) of pain in a 0 to 10cm scoring bar

  • Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity [ Time Frame: From the completion of cesarean (1 day) to one week follow-up ] [ Designated as safety issue: Yes ]
  • Psychological state [ Time Frame: From one day to one week follow-up after cesarean ] [ Designated as safety issue: No ]
    This will be assessed with self anxiety and depression scales

  • Infant weight [ Time Frame: Three min after cesarean section ] [ Designated as safety issue: No ]
  • One-min Apgar score [ Time Frame: One min after cesarean section ] [ Designated as safety issue: Yes ]
  • Five-min Apgar score [ Time Frame: Five min after cesarean section ] [ Designated as safety issue: Yes ]
  • Intraoperative vital signs [ Time Frame: From the beginning of cesarean (0 min) to completion of operation (45 min) ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Parturients received spinal anesthesia
 Procedure: Spinal anesthesia
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
Other Name: Intrathecal anesthesia
Active Comparator: 2
Parturients received epidural anesthesia
 Procedure: Epidural anesthesia
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
Other Name: Extradural anesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872248

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00872248     History of Changes
Other Study ID Numbers: NMU-200903-MZ005, NJFY09102M112
Study First Received: March 30, 2009
Last Updated: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Restless leg syndrome
Spinal anesthesia
Epidural anesthesia
Neuraxial block

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
 Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013