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Spinal anesthesia for elective cesarean section. Use of local anesthetic at different doses of Fentanyl. Randomized Clinical Trial

Spinal anesthesia for elective cesarean section. Use of the Bupivacaine Association at Different doses of Fentanyl. Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5xwt6t
Enrollment
Unknown
Registered
2019-10-18
Start date
2017-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Interventions

The research subjects were randomly assigned (by lot) into 4 groups of 31 patients. The research subjects in group 4 corresponded to the placebo group (not treated with fentanyl). All 124 patients rec
Group II: 0.5% hyperbaric bupivacaine (2.0mL = 10mg) + fentanyl (0.2mL = 10mcg) + 0.9% saline (0.8 mL)
Group III: 0.5% hyperbaric bupivacaine (2.0mL = 10mg) + fentanyl (0.15mL = 7.5mcg) + 0.9% saline (0.85mL)
Group IV (placebo): 0.5% hyperbaric bupivacaine (2.0mL = 10mg) + 0.9% saline (1.0 mL) In addition to enabling anesthetic complementation, the epidural catheter was also used for injection of 2mg morph
Procedure/surgery
E03.155.086.331

Sponsors

Centro de Atenção Integral à Saúde da Mulher - Universidade Estadual de Campinas
Lead Sponsor
Centro de Atenção Integral à Saúde da Mulher - Universidade Estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASA II or III; pregnant women; elective cesarean; age range from 18 to 65 years.

Exclusion criteria

Exclusion criteria: Chronic Fetal distress; acute fetal distress; body mass index higher than 40

Design outcomes

Primary

MeasureTime frame
Evaluate the duration of analgesia, from the beginning of anesthesia to the first spontaneous complaint of pain reported by the patient over than 3, according to the numeric-verbal scale. in that scale, 0 means no pain and 10 the worst pain in the world for the person. ;To evaluate the quality of the intraoperative anesthesia, using a qualitative scale proposed by Lee (excellent, good, fair and poor)—

Secondary

MeasureTime frame
Evaluate the results of fetal vitality, using the Apgar index;Assess the presence of maternal side effects: nausea, vomiting, and pruritus;Quantify the duration of the motor block: time elapsed between the end of the anesthetic injection in the subarachnoid space until the free movement of lower limbs—

Countries

Brazil

Contacts

Public ContactAngélica de Assunção Braga

Centro de Atenção Integral à Saúde da Mulher - Universidade Estadual de Campinas

afbraga@fcm.unicamp.br+55-19-35219333

Outcome results

None listed

Source: REBEC (via WHO ICTRP)