Clonidine in Ultrasound-guided Rectus Sheath Block for Outpatient Umbilical Hernioplasty

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidade Federal do Rio de Janeiro

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Rectus Sheath Block

    Drug

    Participants 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

    Drug

    Participants 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

62 Participants
are divided into 2 treatment groups
Group A: Rectus Sheath BlockActive comparator 1 intervention
Group B: Rectus sheath block with clonidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
48 hours postoperative
2

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.

Time frame
At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
3

Total intraoperative opioid consumption

Total intraoperative fentanyl consumption

Time frame
From induction of anesthesia to the end of surgery.

Secondary outcomes

1

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.

Time frame
At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
2

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.

Time frame
48 hours postoperatively

Other outcomes

1

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.

Time frame
At post-anesthesia care unit (PACU) admission (immediately after surgery).
2

Bradycardia

Incidence of bradycardia

Time frame
From the start of surgery until discharge from the post-anesthesia care unit (PACU), 2 hours after surgery.
3

Hypotension

Incidence of hypotension

Time frame
From the start of surgery until discharge from the post-anesthesia care unit (PACU), 2 hours after surgery.

Sponsors and contacts

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