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Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean (NARELESS)

Primary Purpose

Cesarean Section, Restless Leg Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spinal anesthesia
Epidural anesthesia
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Parturients received spinal anesthesia

Parturients received epidural anesthesia

Outcomes

Primary Outcome Measures

Occurrence of restless leg syndrome

Secondary Outcome Measures

Intraoperative anesthetic effectiveness
The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means
Postoperative analgesic effectiveness
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
Psychological state
This will be assessed with self anxiety and depression scales
Infant weight
One-min Apgar score
Five-min Apgar score
Intraoperative vital signs

Full Information

First Posted
March 30, 2009
Last Updated
July 26, 2011
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00872248
Brief Title
Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean
Acronym
NARELESS
Official Title
Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Restless Leg Syndrome
Keywords
Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Parturients received spinal anesthesia
Arm Title
2
Arm Type
Active Comparator
Arm Description
Parturients received epidural anesthesia
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Other Intervention Name(s)
Intrathecal anesthesia
Intervention Description
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
Intervention Type
Procedure
Intervention Name(s)
Epidural anesthesia
Other Intervention Name(s)
Extradural anesthesia
Intervention Description
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
Primary Outcome Measure Information:
Title
Occurrence of restless leg syndrome
Time Frame
One day to one week after completion of cesarean
Secondary Outcome Measure Information:
Title
Intraoperative anesthetic effectiveness
Description
The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means
Time Frame
From the beginning of anesthesia (0 min) to completion of cesarean (45 min)
Title
Postoperative analgesic effectiveness
Description
This will be assessed with visual analog scale (VAS) of pain in a 0 to 10cm scoring bar
Time Frame
From the initiation of analgesia (0 min) to 48 h after cesarean
Title
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
Title
Psychological state
Description
This will be assessed with self anxiety and depression scales
Time Frame
From one day to one week follow-up after cesarean
Title
Infant weight
Time Frame
Three min after cesarean section
Title
One-min Apgar score
Time Frame
One min after cesarean section
Title
Five-min Apgar score
Time Frame
Five min after cesarean section
Title
Intraoperative vital signs
Time Frame
From the beginning of cesarean (0 min) to completion of operation (45 min)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

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