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The Analgesia of Pregabalin and Magnesium Sulphate in the postoperative period of Mastectomy with Axillary Lymphadenectomy

The Analgesic Effect of Pregabalin and Magnesium Sulfate in the postoperative period of Mastectomy with Axillary Lymphadenectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-59m3sj
Enrollment
Unknown
Registered
2018-03-14
Start date
2015-03-01
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

Women

Interventions

The group 1 - 20 patients - Pregabalin + Placebo received pregabalin 150 mg orally 30 minutes before the anesthetic procedure and 12 hours after this dose and during the surgical procedure they used s
Drug

Sponsors

Instituto do Câncer do Ceará
Lead Sponsor
Instituto do Câncer do Ceará
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: women over eighteen years of age; indicated the mastectomy with axillary lymphadenectomy; state physical classification of the American Society of Anesthesiologist (ASA) I and II; with the signed free informed consent form; no history of allergy to pregabalin or magnesium.

Exclusion criteria

Exclusion criteria: patients with previous history of liver or kidney disease or any other pathology that contraindicated the use of pregabalin or magnesium; who had used opioids 48 hours before surgery. patient who would perform breast reconstruction at the same surgical time. patients using calcium channel blockers

Design outcomes

Primary

MeasureTime frame
expected outcome 1: better analgesia in the magnesium + pregabalin sulfate group using the visual analogue scale to quantify the pain, using the mean + standard deviation, adopting a 95% confidence level when comparing the four groupss;endpoint found 1: decreased pain in the magnesium sulphate + pregabalin group, visual analogue scale of 1.45 ± 2.33; significantly better analgesia than the other groups with a variation lower than 0.001

Secondary

MeasureTime frame
expected secondary outcome 1: longer extubation time in the groups using magnesium sulfate, calculated with the time of anesthesia, using mean ± standard deviation and variation less than 5% when compared to the other groups;secondary outcome found 1: there was no increase in the time of extubation in the groups that used magnesium sulphate when compared with the groups that did not use magnesium sulphate; calculated through the time of anesthesia; using the mean + standard deviation, 117.94 ± 26.44 minutes with a change of 0.613

Countries

Brazil

Contacts

Public ContactJose Nilson Araujo

Instituto do Câncer do Ceará

nilsonfortaleza@gmail.com+55-085-999851123

Outcome results

None listed

Source: REBEC (via WHO ICTRP)