About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Rectus Sheath Block
DrugParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1%, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine.
Rectus Sheath Block with Clonidine
DrugParticipants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with a solution containing 8 mL of lidocaine 2% + 8 mL of ropivacaine 1% + clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, each side, without the addition of clonidine.
Treatment groups
Trial outcomes
Primary outcomes
Total opioid postoperative consumption
Total amount of opioid analgesics (in milligrams of tramadol equivalents) administered from the end of the surgical procedure to 48 hours postoperatively.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS)
Pain scores reported by the patient using the 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain) at each time point.
Total intraoperative opioid consumption
Total intraoperative fentanyl consumption
Secondary outcomes
Quality of recovery assessed by QoR-15 questionnaire
Patient-reported recovery quality measured using the Quality of Recovery-15 (QoR-15) instrument, scored from 0 to 150, with higher scores indicating better recovery.
Incidence of postoperative nausea and vomiting (PONV)
Number of patients who experience at least one episode of nausea and/or vomiting in the first 48 hours after surgery.
Other outcomes
Postoperative Richmond Agitation-Sedation Scale (RASS) sedation score
The Richmond Agitation-Sedation Scale (RASS) is a 10-point scale used to assess the level of sedation and agitation in patients. The scale ranges from -5 (unarousable) to +4 (combative), where higher positive scores indicate higher levels of agitation (worse outcome), and lower negative scores indicate deeper sedation (also considered a worse outcome depending on clinical context). A score of 0 corresponds to an alert and calm patient, which is considered optimal.
Bradycardia
Incidence of bradycardia
Hypotension
Incidence of hypotension
Sponsors and contacts
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