Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

Cesarean Section Clinical Trial

— NARELESS  

Official title:

Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872248
• Other study ID #: NMU-200903-MZ005
• Secondary ID: NJFY09102M112
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: July 26, 2011
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section
• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Syndrome

Intervention

Procedure:
• Spinal anesthesia
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
• Epidural anesthesia
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of restless leg syndrome		One day to one week after completion of cesarean	Yes
Secondary	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)	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Psychological state	This will be assessed with self anxiety and depression scales	From one day to one week follow-up after cesarean	No
Secondary	Infant weight		Three min after cesarean section	No
Secondary	One-min Apgar score		One min after cesarean section	Yes
Secondary	Five-min Apgar score		Five min after cesarean section	Yes
Secondary	Intraoperative vital signs		From the beginning of cesarean (0 min) to completion of operation (45 min)	Yes