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

Primary Purpose

Complications; Cesarean Section

Status

Unknown status

Phase

Phase 4

Locations

Chile

Study Type

Interventional

Intervention

H-Bupivacaine

Fentanyl

About this trial

This is an interventional treatment trial for Complications; Cesarean Section focused on measuring Anesthesia, Spinal and Epidural, Adverse Effect, Complications

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital Clinico Pontificia Universidad CatolicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

H-Bupivacaine 11.5 mg + fentanyl 25 mcg.

H-Bupivacaine 11.5 mg.

Arm Description

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%

Outcomes

Primary Outcome Measures

Change in Punctate - Von frey (grams)

Secondary Outcome Measures

Change in Pressure pain - algometer (kg/cm/cm)

Full Information

NCT ID

NCT02387060

First Posted

February 25, 2015

Last Updated

March 7, 2015

Sponsor

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT02387060

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complications; Cesarean Section

Keywords

Anesthesia, Spinal and Epidural, Adverse Effect, Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

H-Bupivacaine 11.5 mg + fentanyl 25 mcg.

Arm Type

Experimental

Arm Description

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.

Arm Title

H-Bupivacaine 11.5 mg.

Arm Type

Active Comparator

Arm Description

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%

Intervention Type

Drug

Intervention Name(s)

H-Bupivacaine

Other Intervention Name(s)

Hyperbaric bupivacaine

Intervention Description

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

Intrathecal administration of fentanyl 25 mcg

Primary Outcome Measure Information:

Title

Change in Punctate - Von frey (grams)

Time Frame

Change from Baseline in punctate sensibility at 48 hours

Secondary Outcome Measure Information:

Title

Change in Pressure pain - algometer (kg/cm/cm)

Time Frame

Change from Baseline in pressure pain at 48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Carlos De la Cuadra, MD

Phone

+56-2-23543270

juancarl@med.puc.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Hernan Auad, MD

Phone

+56-2-23543270

hernan_auad@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis I Cortinez, MD

Organizational Affiliation

Ponticia Universidad Católica

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Clinico Pontificia Universidad Catolica

City

Santiago

State/Province

Región Metropolitana

ZIP/Postal Code

8330024

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hernan Auad, MD

Phone

56982933226

hernan_auad@hotmail.com

First Name & Middle Initial & Last Name & Degree

Juan Carlos de la Cuadra, MD

12. IPD Sharing Statement

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

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