Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Restless Leg Syndrome
• Intervention / Treatment: Procedure: Spinal anesthesia; Procedure: Epidural anesthesia

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): July 27, 2011
• Last Update Submitted That Met QC Criteria: July 26, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Epidural anesthesia; Restless leg syndrome; Neuraxial block
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: NMU-200903-MZ005; NJFY09102M112