Evaluation of the Preventive Effect of Pain by the Use of Melatonin During Female Sterilization Surgery

Evaluation of Melatonin Analgesic Effects Used in the Perioperative Period of Bilateral Tubal Ligation: Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2685h6

Enrollment

Unknown

Registered

2018-04-18

Start date

2018-06-01

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

Analgesia. Tubal sterilization

Interventions

Intervention group: 34 women undergoing tubal sterilization will receive melatonin tablet 6 milligrams orally 90 minutes prior to tubal sterilization. Control group: 34 women undergoing tubal steriliz

Drug

D03.633.100.473.914.481

HP3.073.433.101

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women scheduled for bilateral tubal ligation; age between 18 and 65 years.

Exclusion criteria

Exclusion criteria: Pregnant patients; history of intolerance or chronic use of opioids or other medications proposed in the study; chronic use or known melatonin intolerance; addicted to alcohol or drugs; use of analgesics, opioids or not, within 24 hours prior to the procedure; inability to provide informed consent and low easily identifiable cognition; patients who present contraindication to neuroaxis blockade.

Design outcomes

Primary

Measure	Time frame
Improvement of acute pain in the perioperative period of female surgical sterilization with decreased levels of pain assessed by means of the Numeral Verbal Scale (NVE) of pain in the periods of 10,20,30,40,50,60 minutes and 6,12,18 and 24 hours after surgery with a pain scale score of less than 4 in the melatonin group compared to values greater than 5 in the control group	—

Secondary

Measure	Time frame
Expected outcome 2: decreased need for complementary doses of analgesics in the intraoperative and postoperative periods evaluated by means of medical record in the periods of 10,20,30,40,50,60 minutes and 6,12,18 and 24 hours after surgery demonstrating use of lower doses by patients in the melatonin group compared to placebo;Expected outcome 3: improvement of the level of patient satisfaction assessed through the Quality of Recovery-40 (QoR-40) scale with patients in the placebo group presenting a higher score regarding the satisfaction of the surgical recovery with values close to 200 when compared to the placebo group may have values below 150;Expected outcome 1: decreased preoperative anxiety assessed using the Spielberg State Anxiety Inventory (STD) with values less than 33 in patients in the melatonin group measured 90 minutes after dosing	—

Measure

Time frame

Expected outcome 2: decreased need for complementary doses of analgesics in the intraoperative and postoperative periods evaluated by means of medical record in the periods of 10,20,30,40,50,60 minutes and 6,12,18 and 24 hours after surgery demonstrating use of lower doses by patients in the melatonin group compared to placebo;Expected outcome 3: improvement of the level of patient satisfaction assessed through the Quality of Recovery-40 (QoR-40) scale with patients in the placebo group presenting a higher score regarding the satisfaction of the surgical recovery with values close to 200 when compared to the placebo group may have values below 150;Expected outcome 1: decreased preoperative anxiety assessed using the Spielberg State Anxiety Inventory (STD) with values less than 33 in patients in the melatonin group measured 90 minutes after dosing

—

Countries

Brazil

Contacts

Public ContactVaniely de Queiroz

Universidade Estadual Paulista "Júlio de Mesquita Filho"

vanielyk@gmail.com+55-083-999997539

Outcome results

None listed

Source: REBEC (via WHO ICTRP)