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NCT Number: NCT00872248

Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia

Procedure

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

Other names: Intrathecal anesthesia

epidural anesthesia

Procedure

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

Other names: Extradural anesthesia

Primary outcomes

  1. Occurrence of restless leg syndrome

    Time frame: One day to one week after completion of cesarean

Secondary outcomes

  1. Intraoperative anesthetic effectiveness

    Time frame: 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

  2. Postoperative analgesic effectiveness

    Time frame: 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

  3. Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity

    Time frame: From the completion of cesarean (1 day) to one week follow-up

  4. Psychological state

    Time frame: From one day to one week follow-up after cesarean

    This will be assessed with self anxiety and depression scales

  5. Infant weight

    Time frame: Three min after cesarean section

  6. One-min Apgar score

    Time frame: One min after cesarean section

  7. Five-min Apgar score

    Time frame: Five min after cesarean section

  8. Intraoperative vital signs

    Time frame: From the beginning of cesarean (0 min) to completion of operation (45 min)

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery

Acronym: NARELESS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2009
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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