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

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02387060
• Other study ID #: 13-389
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2015
• Last updated: March 7, 2015
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: Juan Carlos De la Cuadra, MD
• Phone: +56-2-23543270
• Email: juancarl[@]med.puc.cl
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Hyperalgesia

Intervention

Drug:
• H-Bupivacaine
Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%
• Fentanyl
Intrathecal administration of fentanyl 25 mcg

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad Catolica	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Punctate - Von frey (grams)		Change from Baseline in punctate sensibility at 48 hours	No
Secondary	Change in Pressure pain - algometer (kg/cm/cm)		Change from Baseline in pressure pain at 48 hours	No