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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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H-Bupivacaine 11.5 mg + fentanyl 25 mcg.

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

Group Type EXPERIMENTAL

H-Bupivacaine

Intervention Type DRUG

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

Fentanyl

Intervention Type DRUG

Intrathecal administration of fentanyl 25 mcg

H-Bupivacaine 11.5 mg.

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%

Group Type ACTIVE_COMPARATOR

H-Bupivacaine

Intervention Type DRUG

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

Interventions

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H-Bupivacaine

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

Intervention Type DRUG

Fentanyl

Intrathecal administration of fentanyl 25 mcg

Intervention Type DRUG

Other Intervention Names

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Hyperbaric bupivacaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No