Clinical trial NCT00872248: Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean
Official title: Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Restless Leg Syndrome
Keywords: Restless leg syndrome
Spinal anesthesia
Epidural anesthesia
Neuraxial block
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of restless leg syndrome
timeFrame: One day to one week after completion of cesarean
Secondary outcomes:
measure: Intraoperative anesthetic effectiveness
timeFrame: From the beginning of anesthesia (0 min) to completion of cesarean (45 min)
measure: Postoperative analgesic effectiveness
timeFrame: From the initiation of analgesia (0 min) to 48 h after cesarean
measure: Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity
timeFrame: From the completion of cesarean (1 day) to one week follow-up
measure: Psychological state
timeFrame: From one day to one week follow-up after cesarean
measure: Infant weight
timeFrame: Three min after cesarean section
measure: One-min Apgar score
timeFrame: One min after cesarean section
measure: Five-min Apgar score
timeFrame: Five min after cesarean section
measure: Intraoperative vital signs
timeFrame: From the beginning of cesarean (0 min) to completion of operation (45 min)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: