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Evaluation of analgesia provided by the use of Morphine or Methadone in women undergoing Laparoscopic Surgery

Morphine versus Methadone as postoperative analgesia in women undergoing Laparoscopic Surgery: a randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6j4kw7q
Enrollment
Unknown
Registered
2023-09-20
Start date
2023-10-01
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

Postoperative Pain

Interventions

A prospective, randomized, double-blind clinical trial in which patients will be randomized to the morphine or methadone groups following a simple allocation list generated by the random.org - True Ra

Sponsors

Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Lead Sponsor
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women undergoing clinical follow-up for gynecological pathologies at the Center for Integral Attention to Women's Health - CAISM; 18 years or older, regardless of ethnicity or race; elective surgeries; laparoscopic surgery

Exclusion criteria

Exclusion criteria: Patients who have chronic pain; patients who are regularly using opioids; patients using illicit drugs; patients diagnosed with dementia; patients who do not understand the Portuguese language; patients with allergy to local anesthetics or to all non-steroidal anti-inflammatory drugs (ketoprofen, tenoxicam, diclofenac, dipyrone, paracetamol)

Design outcomes

Primary

MeasureTime frame
Use the visual analog scale method to evaluate the analgesia provided by methadone compared to morphine in the first 24 hours, at rest and on movement, on the patient's arrival, after 2 hours, after 6 and after 24 hours of arrival in the recovery room. Methadone can reduce pain in the postoperative period in the first 24 hours at rest and on movement

Secondary

MeasureTime frame
To evaluate the consumption of remifentanil, in milligrams, after the end of anesthesia, among patients who received methadone compared to those who received morphine. Methadone may reduce intraoperative remifentanil consumption compared to morphine use;To evaluate the incidence of nausea and vomiting in the postoperative period among patients who received methadone compared to those who received morphine, checking its presence or absence on arrival in the post-anesthetic recovery room, two hours later, six hours later and after 24 hours. Methadone may reduce the incidence of nausea and vomiting in the immediate postoperative period compared to morphine;Evaluate the incidence of drowsiness in the postoperative period in patients who received methadone compared to those who received morphine, using the Ramsay Scale method, graded from 1 to 6, at the time of arrival in the post-anesthetic recovery room and after two hours. Methadone may reduce the incidence of drowsiness in the immediate postoperative period compared to morphine;Check for changes in the QTc interval in milliseconds in patients receiving methadone compared to those receiving morphine intraoperatively, evaluated by the Nihon Kohden multiparameter monitor. The Qtc interval of patients receiving high doses of methadone can increase, which can predispose them to malignant arrhythmias. We will see if it is possible to observe any changes in the QTc interval with the present dose, which is considered a low dose;To evaluate quality of life using the WHOQOL-BREF questionnaire and pain using the visual analog scale (VAS) of patients after three months during outpatient visits in the groups receiving morphine and methadone. Methadone may cause a better numerical quality of life score measured by the WHOQOL-BREF compared to morphine. It is expected that there will be no difference in numerical pain scores on the visual analog scale (VAS) between the methadone and morphine groups

Countries

Brazil

Contacts

Public ContactIdelberto Ribeiro Junior

Universidade Estadual de Campinas - UNICAMP

idelbert@unicamp.br+55(19)3251-9360

Outcome results

None listed

Source: REBEC (via WHO ICTRP)