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Pregabalin Antiemetic Effect in Breast Reconstrution Surgery of Patients After Bariatric Surgery.

Pregabalin Antiemetic Effect in Breast Reconstrution Surgery of Patients After Bariatric Surgery. Prospective, Randomised and Double-Blind Study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8y4bvbw
Enrollment
Unknown
Registered
2021-08-30
Start date
2019-08-06
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

Prevention of postoperative nausea, vomiting and pain in patient undergoing breast reconstruction after bariatric surgery.

Interventions

Administration of 75mg of pregabalin in 26 patients undergoing breast reconstruction after bariatric surgery or placebo in 26 patients undergoing breast reconstruction after bariatric surgery, orally,

Sponsors

Rafael Reis Fernandes
Lead Sponsor
Rafael Reis Fernandes
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Female gender; age between eighteen and sixty-four years; physical state classified by the American Society of Anesthesiology scale one and two; breast reconstruction surgery after bariatric surgery.

Exclusion criteria

Exclusion criteria: Volunteers with participation in another study in the last month; smokers and alcoholics; body mass index greater than thirty-five kg / m2; occurrence of episodes of nausea or vomiting in the last twenty-four hours preceding the surgery; use of corticosteroids, use of psychoactive drugs or any medication with antiemetic effect; known hypersensitivity to any study medication; volunteers with severe kidney, liver, lung, heart, brain and bone marrow diseases; volunteers who had a history of postoperative vomiting or unavoidable vomiting even after the administration of rescue medication.

Design outcomes

Primary

MeasureTime frame
To evaluate the antiemetic, effect through the use of pregabalin or placebo, to observe the frequency and intensity of individual episodes of nausea and the frequency of vomiting, in the first 24 postoperative hours.

Secondary

MeasureTime frame
Evaluate the analgesic effect, using pregabalin or placebo, to observe the frequency, intensity and characteristics of postoperative pain.;Assess the incidence of adverse effects due to the use of pregabalin.;To assess the incidence of chronic pain, using pregabalin or placebo, in the late postoperative period of 3 months.

Countries

Brazil

Contacts

Public ContactRafael Fernandes
rafareis.rs@globo.com+55-021-992250604

Outcome results

None listed

Source: REBEC (via WHO ICTRP)