Cesarean SectionNARELESSNCT00872248
Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean
A study testing Spinal anesthesia and Epidural anesthesia in people with Cesarean Section and Restless Leg Syndrome, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section, Restless Leg Syndrome
- What is being tested?
- Spinal anesthesia and Epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnancy
- Selective cesarean
- Gestational age >= 37 weeks
- Chinese
Who cannot join
- Allergic to local anesthetics
- Allergic to opioids
- History of psychosis
- Cognition malfunction
- Any organic diseases
- Original lower extremity dyskinesia and paraesthesia
Show all 9Show fewer
- Chronic pain
- Difficult in sleep
- Drug and alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
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.
- Conditions
- Cesarean Section, Restless Leg Syndrome
- Being tested
- Spinal anesthesia, Epidural anesthesia
- Keywords
- Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Also called Intrathecal anesthesia
Procedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg
Epidural anesthesiaProcedure or surgery
Also called Extradural anesthesia
Procedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Parturients received spinal anesthesia Receives: Procedure: Spinal anesthesia |
| 2 | Active comparator | Parturients received epidural anesthesia Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of restless leg syndrome
Measured: One day to one week after completion of cesarean
Secondary outcomes (8)
Intraoperative anesthetic effectiveness
The anesthetic efficacy of neuraxial anesthesia will be assessed with sensony and movement block means
Measured: From the beginning of anesthesia (0 min) to completion of cesarean (45 min)
Postoperative analgesic effectiveness
This will be assessed with visual analog scale (VAS) of pain in a 0 to 10cm scoring bar
Measured: From the initiation of analgesia (0 min) to 48 h after cesarean
Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity
Measured: From the completion of cesarean (1 day) to one week follow-up
Psychological state
This will be assessed with self anxiety and depression scales
Measured: From one day to one week follow-up after cesarean
Infant weight
Measured: Three min after cesarean section
One-min Apgar score
Measured: One min after cesarean section
Five-min Apgar score
Measured: Five min after cesarean section
Intraoperative vital signs
Measured: From the beginning of cesarean (0 min) to completion of operation (45 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872248
- Sponsor's protocol ID
- NMU-200903-MZ005
- Other IDs
- NJFY09102M112
- Acronym
- NARELESS
- Status last verified
- May 2011
- First submitted
- 30 Mar 2009
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00872248
- Acronym / sponsor ID
- NARELESS / NMU-200903-MZ005
- Conditions
- Cesarean Section, Restless Leg Syndrome
- Keywords
- Restless leg syndrome, Spinal anesthesia, Epidural anesthesia, Neuraxial block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Spinal anesthesiaParturients received spinal anesthesia |
| 2 | Active comparator | Procedure: Epidural anesthesiaParturients received epidural anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnancy
- Selective cesarean
- Gestational age >= 37 weeks
- Chinese
Key exclusion criteria (9 listed)
- Allergic to local anesthetics
- Allergic to opioids
- History of psychosis
- Cognition malfunction
- Any organic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaAlso: Intrathecal anesthesiaProcedures of spinal anesthesia with bupivacaine 0.5%, 10-15mg | Procedure or surgery | 1 |
| Epidural anesthesiaAlso: Extradural anesthesiaProcedures of epidural anesthesia with ropivacaine 0.75%, 75-120mg | Procedure or surgery | 2 |
Primary outcome
Occurrence of restless leg syndrome
Time frame: One day to one week after completion of cesarean
8 secondary outcomes
Intraoperative anesthetic effectiveness
Time frame: From the beginning of anesthesia (0 min) to completion of cesarean (45 min)
Postoperative analgesic effectiveness
Time frame: From the initiation of analgesia (0 min) to 48 h after cesarean
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
Psychological state
Time frame: From one day to one week follow-up after cesarean
Infant weight
Time frame: Three min after cesarean section
One-min Apgar score
Time frame: One min after cesarean section
Five-min Apgar score
Time frame: Five min after cesarean section
Intraoperative vital signs
Time frame: From the beginning of cesarean (0 min) to completion of operation (45 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia and Epidural anesthesia in people with Cesarean Section and Restless Leg Syndrome, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of restless leg syndrome (time frame: One day to one week after completion of cesarean). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.