NCT00872248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

March 30, 2009

Last Update Submit

July 26, 2011

Conditions

Cesarean SectionRestless Leg Syndrome

Keywords

Restless leg syndromeSpinal anesthesiaEpidural anesthesiaNeuraxial block

Outcome Measures

Primary Outcomes (1)

  • Occurrence of restless leg syndrome

    One day to one week after completion of cesarean

Secondary Outcomes (8)

  • Intraoperative anesthetic effectiveness

    From the beginning of anesthesia (0 min) to completion of cesarean (45 min)

  • Postoperative analgesic effectiveness

    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

    From one day to one week follow-up after cesarean

  • Infant weight

    Three min after cesarean section

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Parturients received spinal anesthesia

Procedure: Spinal anesthesia

2

ACTIVE COMPARATOR

Parturients received epidural anesthesia

Procedure: Epidural anesthesia

Interventions

Spinal anesthesiaPROCEDURE

Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg

Also known as: Intrathecal anesthesia
1
Epidural anesthesiaPROCEDURE

Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg

Also known as: Extradural anesthesia
2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy pregnancy
  • Selective cesarean
  • Gestational age \>= 37 weeks
  • Chinese

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Anesthesia, SpinalAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-05

Locations

CN(1)