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

NCT02387060 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-03-12

No results posted yet for this study

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.

Conditions

  • Complications; Cesarean Section

Interventions

DRUG

H-Bupivacaine

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

DRUG

Fentanyl

Intrathecal administration of fentanyl 25 mcg

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Luis I Cortinez, MD · Ponticia Universidad Católica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Chile

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387060 on ClinicalTrials.gov