Cesarean Section, Restless Leg Syndrome
Conditions
Keywords
Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block
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.
Interventions
PROCEDURESpinal anesthesia
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
PROCEDUREEpidural anesthesia
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of restless leg syndrome | One day to one week after completion of cesarean |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) | — |
| Infant weight | Three min after cesarean section | — |
Countries
China
Outcome results
None listed