Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

Not Applicable

Completed

• Conditions: Cesarean Section; Restless Leg Syndrome
• Interventions: Procedure: Spinal anesthesia; Procedure: Epidural anesthesia

• Registration Number: NCT00872248
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Spinal anesthesia	Parturients received spinal anesthesia
2	Epidural anesthesia	Parturients received epidural anesthesia

Primary Outcome Measures

Name	Time	Method
Occurrence of restless leg syndrome	One day to one week after completion of cesarean

Secondary Outcome Measures

Name	Time	Method
Intraoperative anesthetic effectiveness	From the beginning of anesthesia (0 min) to completion of cesarean (45 min)	The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means
Postoperative analgesic effectiveness	From the initiation of analgesia (0 min) to 48 h after cesarean	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	From the completion of cesarean (1 day) to one week follow-up
Psychological state	From one day to one week follow-up after cesarean	This will be assessed with self anxiety and depression scales
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)

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China