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

NCT02387060 | Unknown Phase 4

• 1 other identifier: 13-389
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Cesarean Section

Keywords

Anesthesia; Spinal and Epidural; Adverse Effect; Complications

Outcome Measures

Primary Outcomes (1)

• Change in Punctate - Von frey (grams)

  Change from Baseline in punctate sensibility at 48 hours

Secondary Outcomes (1)

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

  Change from Baseline in pressure pain at 48 hours

Study Arms (2)

H-Bupivacaine 11.5 mg + fentanyl 25 mcg.

EXPERIMENTAL

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

Drug: H-Bupivacaine; Drug: Fentanyl

H-Bupivacaine 11.5 mg.

ACTIVE COMPARATOR

Intrathecal administration of Hyperbaric Bupivacaine 1.5 ml 0.75%

Drug: H-Bupivacaine

Interventions

H-Bupivacaine DRUG

Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%

Also known as: Hyperbaric bupivacaine

H-Bupivacaine 11.5 mg + fentanyl 25 mcg.; H-Bupivacaine 11.5 mg.

Fentanyl DRUG

Intrathecal administration of fentanyl 25 mcg

H-Bupivacaine 11.5 mg + fentanyl 25 mcg.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luis I Cortinez, MD

  Ponticia Universidad Católica

  STUDY CHAIR

Central Study Contacts

Juan Carlos De la Cuadra, MD

CONTACT

+56-2-23543270; juancarl@med.puc.cl

Hernan Auad, MD

CONTACT

+56-2-23543270; hernan_auad@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 12, 2015
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

CL (1)