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

Phase 4

• Conditions: Complications; Cesarean Section
• Interventions: Drug: H-Bupivacaine; Drug: Fentanyl

• Registration Number: NCT02387060
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-25
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-07
• Last Update Submitted: 2015-03-07
• Study First Posted: 2015-03-12
• Last Update Posted: 2015-03-12
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H-Bupivacaine 11.5 mg + fentanyl 25 mcg.	Fentanyl	Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.
H-Bupivacaine 11.5 mg.	H-Bupivacaine	Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%
H-Bupivacaine 11.5 mg + fentanyl 25 mcg.	H-Bupivacaine	Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75% plus fentanyl 25 mcg.

Primary Outcome Measures

Name	Time	Method
Change in Punctate - Von frey (grams)	Change from Baseline in punctate sensibility at 48 hours

Secondary Outcome Measures

Name	Time	Method
Change in Pressure pain - algometer (kg/cm/cm)	Change from Baseline in pressure pain at 48 hours

Trial Locations

Locations (1)

Hospital Clinico Pontificia Universidad Catolica; 🇨🇱 Santiago, Región Metropolitana, Chile