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Use of Topical Anesthetic Cream for pain relief caused by the injection of Spinal Anesthesia in elective cesarean sections

Use of 2.5% Lidocaine cream and 2.5% Prilocaine cream for analgesia pre lombar puncture of subaracnoideo blocking in programmed cesarians

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-29xb94
Enrollment
Unknown
Registered
2019-03-15
Start date
2019-05-01
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

Complications of anesthesia given during pregnancy

Interventions

102 patients will be randomly assigned to two different groups: In Group A, 51 women will receive 2.5% lidocaine anesthetic cream + 2.5% prilocaine applied on the entire skin of the region located bet
Drug
Procedure/surgery
E03.155.364
E03.155.086.231

Sponsors

Financiamento Próprio
Lead Sponsor
Financiamento Próprio
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Female patients; over 18 years; pregnant women (above 37 weeks); physical status ASA II; to be submitted to subarachnoid anesthesia for elective cesarean surgery.

Exclusion criteria

Exclusion criteria: Will not be included in the study: Patients who refuse to participate in the study; patients in labor; who are taking any sedative, opioid or sleep inducing drugs; who have a history of allergy to any drug to be used in the study; severe obesity (defined by a BMI of more than 35 kg.m2), methemoglobinemia, carriers of pathologies that cause some cognitive deficit, such as schizophrenia, oligophrenia, severe depression, etc. If this occurs, the patients will be excluded from the clinical trial, but will not suffer harm in their treatment. Patients who begin labor during the latency period of topical medication, who require cesarean section before completing 60 minutes after application of the patch containing the cream (anesthetic or placebo), who request their exclusion from the study, will be excluded from the study. study during their performance, who present an allergic reaction during anesthesia or who present partial or total failure of the anesthetic block.

Design outcomes

Primary

MeasureTime frame
Level of pain during local anesthesia with lidocaine measured by visual analogue pain scale

Secondary

MeasureTime frame
Pain assessment reported by the patients through visual analog pain scale after lumbar puncture.;Check if patients prefer to receive the dermatological anesthetic cream used in a next anesthesia.

Countries

Brazil

Contacts

Public ContactDaniel;Marina Carli;Fernandes

Faculdade de Medicina de Jundiaí;Faculdade de Medicina de Jundiaí

danidkrli@ig.com.br;marina.gasparottof@gmail.com+55(11)999576880;(51)993463654

Outcome results

None listed

Source: REBEC (via WHO ICTRP)