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Trial record 52 of 761 for:    region | Chile

Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean

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ClinicalTrials.gov Identifier: NCT02387060
Recruitment Status : Unknown
Verified March 2015 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : March 12, 2015
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Drug: H-Bupivacaine Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
Study Start Date : August 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: H-Bupivacaine 11.5 mg + fentanyl 25 mcg.
Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.
Drug: H-Bupivacaine
Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%
Other Name: Hyperbaric bupivacaine

Drug: Fentanyl
Intrathecal administration of fentanyl 25 mcg

Active Comparator: H-Bupivacaine 11.5 mg.
Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%
Drug: H-Bupivacaine
Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%
Other Name: Hyperbaric bupivacaine




Primary Outcome Measures :
  1. Change in Punctate - Von frey (grams) [ Time Frame: Change from Baseline in punctate sensibility at 48 hours ]

Secondary Outcome Measures :
  1. Change in Pressure pain - algometer (kg/cm/cm) [ Time Frame: Change from Baseline in pressure pain at 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387060


Contacts
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Contact: Juan Carlos De la Cuadra, MD +56-2-23543270 juancarl@med.puc.cl
Contact: Hernan Auad, MD +56-2-23543270 hernan_auad@hotmail.com

Locations
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Chile
Hospital Clinico Pontificia Universidad Catolica Recruiting
Santiago, Región Metropolitana, Chile, 8330024
Contact: Hernan Auad, MD    56982933226    hernan_auad@hotmail.com   
Principal Investigator: Juan Carlos de la Cuadra, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Study Chair: Luis I Cortinez, MD Ponticia Universidad Católica

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02387060     History of Changes
Other Study ID Numbers: 13-389
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Keywords provided by Pontificia Universidad Catolica de Chile:
Anesthesia
Spinal and Epidural
Adverse Effect
Complications

Additional relevant MeSH terms:
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Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General