Clonidine added to ultrasound-guided rectus sheath block for outpatient umbilical hernia repair
Ultrasound-guided Rectus Abdominis Muscle Sheath Block in Outpatient Umbilical Hernioplasties: a Comparative Analysis of the Use of Clonidine as an Adjuvant - Prospective Randomized Clinical Trial
This trial will test whether adding clonidine to an ultrasound-guided rectus sheath block reduces pain for adults having outpatient umbilical hernia repair.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidade Federal do Rio de Janeiro Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT07062497 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind trial comparing bilateral ultrasound-guided rectus sheath block (RSB) with and without clonidine as the sole anesthetic technique for elective ambulatory umbilical hernioplasty. Adults aged 18–65 with ASA I–II and hernia defects ≤4 cm are randomized to receive identical volumes of local anesthetic with or without 75 mcg clonidine per side under real-time ultrasound guidance. Sedation is given as needed and standard monitoring is used; outcomes include intraoperative and postoperative pain scores, recovery quality, opioid requirements, and side effects recorded up to 48 hours after surgery. The trial is conducted at the ambulatory surgery unit of the Policlínica Universitária Piquet Carneiro in Rio de Janeiro and uses patient questionnaires and clinical monitoring to compare groups.
Who should consider this trial
Good fit: Adults 18–65 years old with ASA physical status I or II scheduled for elective ambulatory umbilical hernia repair with a hernial defect ≤4 cm are ideal candidates.
Not a fit: Patients with larger hernias (>4 cm), contraindications to regional anesthesia, allergy to local anesthetics or clonidine, or ASA III+ conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding clonidine could improve pain control, reduce the need for opioids, and speed recovery after outpatient umbilical hernia repair.
How similar studies have performed: Previous studies have shown clonidine can prolong and improve analgesia when added to other peripheral nerve blocks and RSB has been used for abdominal wall analgesia, but using clonidine-containing RSB as the sole anesthetic for ambulatory umbilical hernioplasty is relatively limited in the literature.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro, Rio de Janeiro
- Policlinica Universitária Piquet Carneiro — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Study coordinator: Samuel N Abreu, MD
- Email: samuel.abreu@ppc.uerj.br
- Phone: 55 21 987901911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.