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

March 7, 2015 updated by: Pontificia Universidad Catolica de Chile

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • Recruiting
        • Hospital Clinico Pontificia Universidad Catolica
        • Contact:
        • Principal Investigator:
          • Juan Carlos de la Cuadra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Punctate - Von frey (grams)
Time Frame: Change from Baseline in punctate sensibility at 48 hours
Change from Baseline in punctate sensibility at 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Pressure pain - algometer (kg/cm/cm)
Time Frame: Change from Baseline in pressure pain at 48 hours
Change from Baseline in pressure pain at 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Study Chair: Luis I Cortinez, MD, Ponticia Universidad Católica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 7, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 7, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-389 (Ethical review board UMC Utrecht)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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