Complications; Cesarean SectionPhase 4NCT02387060
Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
A Phase 4 study testing H-Bupivacaine and Fentanyl in people with Complications; Cesarean Section, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus. Opioid induced hyperalgesia could be an explanation studies in animal models. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- H-Bupivacaine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- Aug 2014to Jan 2016
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant 37 to 41 weeks.
- American Society of Anesthesiologists classificationI or II.
- Between 18 and 40 years.
- Scheduled for elective cesarean section under spinal anesthesia in the Maternity Service of the Clinical Hospital of the Catholic University.
Who cannot join
- Background Of high risk pregnancy. Twin-pregnancy.
- Obesity> 30 kg / m 2 before pregnancy.
- Background Of psychiatric illness.
- Using Chronic analgesic.
- AllergyDrug used in protocol.
- require General anesthesia during surgery
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico Pontificia Universidad Catolica
Santiago, Santiago Metropolitan, 8330024
Hernan Auad, MD, 56982933226, hernan_auad@hotmail.com
Juan Carlos de la Cuadra, MD
About this study
Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus.
Opioid induced hyperalgesia could be an explanation studies in animal models. Through mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and changes in intracellular calcium regulation involved.
Read more
The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a model study in patients undergoing cesarean section to study the secondary hyperalgesia induced based on the study of nociceptive thresholds with two methods opioids: Von Frey filaments and digital algometer.
If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an increase in sensitivity will occur. This increase can be measured by von Frey filaments, expressed in increased requirement clinically opioids.
- Conditions
- Complications; Cesarean Section
- Being tested
- H-Bupivacaine, Fentanyl
- Keywords
- Anesthesia, Spinal and Epidural, Adverse Effect, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-BupivacaineDrug
Also called Hyperbaric bupivacaine
Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%
FentanylDrug
Intrathecal administration of fentanyl 25 mcg
| Study group | Role | What they receive |
|---|---|---|
| H-Bupivacaine 11.5 mg + fentanyl 25 mcg. | Experimental | Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg. Receives: Drug: H-Bupivacaine; Drug: Fentanyl |
| H-Bupivacaine 11.5 mg. | Active comparator | Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% Receives: Drug: H-Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Punctate - Von frey (grams)
Measured: Change from Baseline in punctate sensibility at 48 hours
Secondary outcomes (1)
Change in Pressure pain - algometer (kg/cm/cm)
Measured: Change from Baseline in pressure pain at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis I Cortinez, MD, Study chair, Ponticia Universidad Católica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387060
- Sponsor's protocol ID
- 13-389
- Status last verified
- Mar 2015
- First submitted
- 25 Feb 2015
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
- ClinicalTrials.gov ID
- NCT02387060
- Acronym / sponsor ID
- 13-389
- Conditions
- Complications; Cesarean Section
- Keywords
- Anesthesia, Spinal and Epidural, Adverse Effect, Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 12 Mar 2015 (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.
Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly effective, their use is not without problems. One is the increasing requirement of these address the same nociceptive stimulus.
Opioid induced hyperalgesia could be an explanation studies in animal models. Through mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and changes in intracellular calcium regulation involved.
The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a model study in patients undergoing cesarean section to study the secondary hyperalgesia induced based on the study of nociceptive thresholds with two methods opioids: Von Frey filaments and digital algometer.
If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an increase in sensitivity will occur. This increase can be measured by von Frey filaments, expressed in increased requirement clinically opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H-Bupivacaine 11.5 mg + fentanyl 25 mcg. | Experimental | Drug: H-Bupivacaine, Drug: FentanylIntrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg. |
| H-Bupivacaine 11.5 mg. | Active comparator | Drug: H-BupivacaineIntrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant 37 to 41 weeks.
- American Society of Anesthesiologists classificationI or II.
- Between 18 and 40 years.
- Scheduled for elective cesarean section under spinal anesthesia in the Maternity Service of the Clinical Hospital of the Catholic University.
Key exclusion criteria (6 listed)
- Background Of high risk pregnancy. Twin-pregnancy.
- Obesity> 30 kg / m 2 before pregnancy.
- Background Of psychiatric illness.
- Using Chronic analgesic.
- AllergyDrug used in protocol.
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 |
|---|---|---|
| H-BupivacaineAlso: Hyperbaric bupivacaineIntrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75% | Drug | H-Bupivacaine 11.5 mg + fentanyl 25 mcg., H-Bupivacaine 11.5 mg. |
| FentanylIntrathecal administration of fentanyl 25 mcg | Drug | H-Bupivacaine 11.5 mg + fentanyl 25 mcg. |
Primary outcome
Change in Punctate - Von frey (grams)
Time frame: Change from Baseline in punctate sensibility at 48 hours
1 secondary outcome
Change in Pressure pain - algometer (kg/cm/cm)
Time frame: Change from Baseline in pressure pain at 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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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.
Luis I Cortinez, MD study chair
Ponticia Universidad Católica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing H-Bupivacaine and Fentanyl in people with Complications; Cesarean Section, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos De la Cuadra, MD (+56-2-23543270, juancarl@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Punctate - Von frey (grams) (time frame: Change from Baseline in punctate sensibility at 48 hours). 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 12 Mar 2015.