Labor PainLANCT00626977
Labor Analgesia With Ropivacaine and Clonidine
An observational study of Labor Pain, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- ropivacaine and ropivacaine and clonidine
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- May 2000to Dec 2001
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women having requested epidural analgesia for labor and hers newborns
Who may be able to join
- Singleton healthy
- Full-term pregnancy
- American Society of Anesthesiologists physical status I or II
Who cannot join
- Patients who had received opioids
- History of hypersensitivity to local anesthetic or to clonidine
- Fetus showed signs of possible intrauterine suffering
- Fetus showed signs of possible neurological deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial
The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.
- Conditions
- Labor Pain
- Being tested
- ropivacaine, ropivacaine and clonidine
- Keywords
- Analgesia, Obstetrical, Anesthesia, Epidural, Newborn, Anesthetics, local, Clonidine, Pregnant women, Infant, newborn
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
15 ml of ropivacaine 0.125% peridural once
ropivacaine and clonidineDrug
15 ml of ropivacaine 0.0625% plus 75 mcg clonidine
| Study group | Role | What they receive |
|---|---|---|
| R | R group:15 mL of 0.125% ropivacaine (18.75 mg) Receives: Drug: ropivacaine | |
| RC | RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine Receives: Drug: ropivacaine and clonidine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMay 2000
- Primary completionMay 2000
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Yara Marcondes Machado Castiglia, UPECLIN HC FM Botucatu Unesp
- Investigators
- Giane Nakamura, MD PHd, Principal investigator, College Study of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626977
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-07
- Acronym
- LA
- Status last verified
- Feb 2008
- First submitted
- 20 Feb 2008
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakamura G, Ganem EM, Modolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6. doi: 10.1590/s1516-31802008000200007.
PubMed 18553032
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00626977
- Acronym / sponsor ID
- LA / upeclin/HC/FMB-Unesp-07
- Conditions
- Labor Pain
- Keywords
- Analgesia, Obstetrical, Anesthesia, Epidural, Newborn, Anesthetics, local, Clonidine, Pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- May 2000
- Primary completion
- May 2000 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 29 Feb 2008 (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 aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R | – | Drug: ropivacaineR group:15 mL of 0.125% ropivacaine (18.75 mg) |
| RC | – | Drug: ropivacaine and clonidineRC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women having requested epidural analgesia for labor and hers newborns
Key inclusion criteria (3 listed)
- Singleton healthy
- Full-term pregnancy
- American Society of Anesthesiologists physical status I or II
Key exclusion criteria (4 listed)
- Patients who had received opioids
- History of hypersensitivity to local anesthetic or to clonidine
- Fetus showed signs of possible intrauterine suffering
- Fetus showed signs of possible neurological deficit
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 |
|---|---|---|
| ropivacaine15 ml of ropivacaine 0.125% peridural once | Drug | R |
| ropivacaine and clonidine15 ml of ropivacaine 0.0625% plus 75 mcg clonidine | Drug | RC |
Primary outcome
Not reported in the source record.
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 8 Jul 2015.
- Derived from this study: PubMed 18553032Nakamura G, Ganem EM, Modolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6. doi: 10.1590/s1516-31802008000200007.
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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.
Giane Nakamura, MD PHd principal investigator
College Study of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 3 inclusion and 4 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 8 Jul 2015. 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 Brazil. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626977, which also lists 1 linked publication.
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 8 Jul 2015.