The Facilitatory Effects of Adjuvant Pharmaceutics to Prolong the Duration of Local Anesthetic for Peripheral Nerve Block: A Systematic Review and Network Meta-analysis.
Chengluan Xuan, Wen Yan, Dan Wang...
https://pubmed.ncbi.nlm.nih.gov/34153021Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
ID07062497
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
Led by Universidade Federal do Rio de Janeiro · Updated on 2025-07-14
62
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an ultrasound-guided nerve block technique called rectus sheath block (RSB) as the only anesthetic method for adults undergoing outpatient umbilical hernia surgery. The study compares two groups: one receiving RSB with an added medication called clonidine, and the other receiving RSB without clonidine. The goal is to see if clonidine improves pain control, reduces the need for additional pain medications, and supports better recovery without adding risks. Participants will receive bilateral RSB performed with real-time ultrasound guidance using a specific needle and monitored sedation as needed. The intervention group receives a local anesthetic solution with clonidine, while the control group receives the same anesthetic without clonidine. Both solutions include lidocaine and ropivacaine diluted in saline and administered on each side. The study is randomized, double-blind, and controlled, with careful data management and safety monitoring during surgery. During the first 48 hours after surgery, participants will answer questionnaires assessing pain intensity, recovery quality, and sedation levels. Pain is measured at the recovery unit, 24 hours, and 48 hours post-surgery. Researchers will also track opioid use during and after surgery, as well as any side effects like nausea or vomiting. The study aims to provide important information about improving anesthesia techniques for safer and more comfortable hernia repair.
CONDITIONS
Brief Title
Clonidine in Ultrasound-guided Rectus Sheath Block for Outpatient Umbilical Hernioplasty
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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, 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants receive bilateral ultrasound-guided rectus sheath block (RSB) with or without clonidine before undergoing outpatient umbilical hernioplasty under sedation and standard monitoring.
1 preoperative visit (in-person) on surgery day
Follow-up
Duration - 48 hours postoperative
Participants are assessed for postoperative pain, opioid consumption, recovery quality, and adverse events for 48 hours after surgery.
3 visits: at post-anesthesia care unit admission, 24 hours, and 48 hours after surgery
Trial Site Locations
Total: 1 location
1
Policlinica Universitária Piquet Carneiro
Rio de Janeiro, Rio de Janeiro, Brazil, 20950-003
Actively Recruiting
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Research Team
S
Samuel N Abreu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The addition of clonidine to ropivacaine in rectus sheath nerve blocks for pediatric patients undergoing laparoscopic appendectomy: A double blinded randomized prospective study.
Mihaela Visoiu, Stefan Scholz, Marcus M Malek...
https://pubmed.ncbi.nlm.nih.gov/33752119Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients.
Hyun-Jung Kwon, Yeon Ju Kim, Youngmu Kim...
https://pubmed.ncbi.nlm.nih.gov/36638514The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children.
Giovanni Cucchiaro, Arjunan Ganesh
https://pubmed.ncbi.nlm.nih.gov/17312203