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Postoperative analgesia in gynecological laparoscopy: intraoperative methadone or magnesium sulfate

Post-Laparoscopic gynecological analgesia: Methadone x Magnesium Sulfate. Randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7hmxnkm
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-09-01
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

We calculated a number of 50 participants, 25 in each group. We have increased to 30 participants in each group for compensation for possible losses. Participants will be electronically divided into t

Sponsors

Real e Benemérita Associação Portuguesa de Beneficência
Lead Sponsor
Real e Benemérita Associação Portuguesa de Beneficência
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients scheduled for medium-sized gynecological surgical laparoscopy (hysterectomy, oophorectomy, salpingectomy, endometriosis, without intestinal involvement, without inflammatory disease); who freely agree to sign the consent form and participate in the study

Exclusion criteria

Exclusion criteria: Cases that evolve with serious surgical complications (organ damage, hemorrhage, etc.); widening of the interval between the Q and T waves on the electrocardiogram; heart block other than first-degree atrioventricular block; renal failure; alteration in neuromuscular function; chronic pain in treatment with corticosteroids and/or opioids; allergy/contraindication to any of the study components

Design outcomes

Primary

MeasureTime frame
To evaluate postoperative analgesia after gynecological videolaparoscopy in patients receiving magnesium sulfate or methadone. It is expected to find superior analgesia in patients receiving methadone. The analyzed outcomes will be morphine consumption, postoperative pain scores (30 min after waking up, 6 h after waking up and on the 1st and 2nd PO day after 6 pm), brief pain inventory (pre and 6 h after awakening from anesthesia). Pain will be assessed according to a numerical pain scale (0 to 10, with 0 being no pain and 10 being the worst imaginable pain), explained to patients in the pre-anesthetic evaluation

Secondary

MeasureTime frame
Assess the incidence of nausea and vomiting, time between interruption of anesthesia and SetLine = 50, mini-mental state examination (pre and 3 h after surgery);Assess the incidence of nausea and vomiting, time between interruption of anesthesia and SetLine = 50, mini-mental state examination (pre and 3 h after surgery)

Countries

Brazil

Contacts

Public ContactSebastião Silva Filho

Sociedade Portuguesa de Beneficência de Santos

sebasernesto@gmail.com5512991457764

Outcome results

None listed

Source: REBEC (via WHO ICTRP)