The effect of the anesthetic Clonidine combined with Bupivacaine for pain control in patients who underwent Vitrectomy surgery

Evaluation of the effect of Clonidine associated with Bupivacaine in peribulbar block for patients undergoing Vitrectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-9s9hc29

Enrollment

Unknown

Registered

2025-10-27

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Interventions

This is a prospective, comparative, randomized, double-blind study to evaluate the effect of Clonidine in peribulbar block. The study population will comprise 100 patients undergoing vitrectomy, rando

s content, as will the principal investigator

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years; American Society of Anesthesiologists - ASA physical status I, II or III; of both sexes; undergoing vitrectomy; after signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: Patient refusal of the block; coagulopathy or use of anticoagulants; altered state of consciousness; non-cooperative patient; uncontrolled arterial hypertension; recent acute myocardial infarction (<6 months); glaucoma; recent analgesic therapy (<2 weeks); chronic use of clonidine

Design outcomes

Primary

Measure	Time frame
Expected outcome: To evaluate the time to the first request for analgesic medication; verified through medical record notation of the time in minutes between the end of surgery and the patient's first request for rescue analgesic; based on the comparison of the mean time between groups	—

Secondary

Measure	Time frame
Expected outcome: To evaluate the intensity of postoperative pain at rest; verified through the 0-10 Numeric Rating Scale; based on assessment immediately after the end of surgery (T0) and 24 hours after the procedure;Expected outcome: To evaluate the onset time and duration of eyelid and globe akinesia; verified by standardized clinical assessment before surgery; based on the comparison of the mean time in minutes between the groups;Expected outcome: To evaluate the incidence of postoperative nausea and vomiting; verified through direct questioning of the patient and recording on a data collection form; based on the comparison of the frequency of events between the groups in the first 24 hours;Expected outcome: To evaluate the incidence of adverse effects such as hypotension and bradycardia; verified by recording physiological parameters during intraoperative monitoring; based on the comparison of the frequency of events between the groups	—

Measure

Time frame

Expected outcome: To evaluate the intensity of postoperative pain at rest; verified through the 0-10 Numeric Rating Scale; based on assessment immediately after the end of surgery (T0) and 24 hours after the procedure;Expected outcome: To evaluate the onset time and duration of eyelid and globe akinesia; verified by standardized clinical assessment before surgery; based on the comparison of the mean time in minutes between the groups;Expected outcome: To evaluate the incidence of postoperative nausea and vomiting; verified through direct questioning of the patient and recording on a data collection form; based on the comparison of the frequency of events between the groups in the first 24 hours;Expected outcome: To evaluate the incidence of adverse effects such as hypotension and bradycardia; verified by recording physiological parameters during intraoperative monitoring; based on the comparison of the frequency of events between the groups

—

Countries

Brazil

Contacts

Public ContactCaio Marcio Barros de Oliveira

Universidade Federal do Maranhão

caio.marcio@ufma.br+55 (98) 981810055

Outcome results

None listed

Source: REBEC (via WHO ICTRP)