NCT07062497 Clonidine in Ultrasound-guided Rectus Sheath Block for Outpatient Umbilical Hernioplasty
| NCT ID | NCT07062497 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Universidade Federal do Rio de Janeiro |
| Condition | Hernia, Umbilical |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2025-12-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2025-01-07 with a primary completion date of 2025-12-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to evaluate the effectiveness of an ultrasound-guided nerve block technique as the sole anesthetic method for patients undergoing outpatient umbilical hernia surgery. The procedure, called rectus sheath block (RSB), involves injecting local anesthetic near the abdominal muscles to reduce pain during and after surgery. The study will compare two groups of adult patients: one receiving the nerve block with a medication called clonidine added to the anesthetic solution, and the other receiving the same block without clonidine. Clonidine may help improve pain control and reduce the need for additional pain medications. By analyzing pain scores, recovery quality, and potential side effects, the study seeks to determine whether the use of clonidine in this context is safe, cost-effective, and beneficial for patient recovery. Participants will answer questionnaires about their pain and recovery during the first 48 hours after surgery.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 to 65 years; * Both male and female participants; * ASA physical status I or II (American Society of Anesthesiologists classification); * Scheduled for elective ambulatory umbilical hernia repair; * Hernial defect size ≤ 4 cm (small to medium). Exclusion Criteria: * Refusal or inability to provide written informed consent; * Cognitive or psychiatric disorders that impair comprehension or adherence to the study protocol; * Known allergy or hypersensitivity to local anesthetics, clonidine, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics; * Participation in another clinical trial within the previous 30 days; * Missing data or loss to follow-up during postoperative assessments; * Contraindications to regional anesthesia or known coagulopathy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07062497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hernia, Umbilical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07062497 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07062497 currently recruiting?
Yes, NCT07062497 is actively recruiting participants. Contact the research team at samuel.abreu@ppc.uerj.br for enrollment information.
Where is the NCT07062497 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT07062497 clinical trial?
NCT07062497 is sponsored by Universidade Federal do Rio de Janeiro. The trial plans to enroll 62 participants.