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

NCT07062497 | Recruiting Phase 2

• 2 other identifiers: 83635224.9.0000.5259111111111111
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Umbilical; Clonidine; Pain, Postoperative; Ambulatory Surgical Procedures; Regional Anesthesia Block

Keywords

Rectus Sheath Block; Ultrasound-Guided Regional Anesthesia; Umbilical Hernia Repair; Clonidine; Local Anesthetics; Postoperative Pain Management; Ambulatory Surgery; Quality of Recovery; Alpha-2 Adrenergic Agonists; Pain Measurement; Analgesic Adjuvants

Outcome Measures

Primary Outcomes (3)

• 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.

  48 hours postoperative

• 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.

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

• Total intraoperative opioid consumption

  Total intraoperative fentanyl consumption

  From induction of anesthesia to the end of surgery.

Secondary Outcomes (2)

• Quality of recovery assessed by QoR-15 questionnaire

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

• Incidence of postoperative nausea and vomiting (PONV)

  48 hours postoperatively

Other Outcomes (3)

• Postoperative Richmond Agitation-Sedation Scale (RASS) sedation score

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

• Bradycardia

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

• Hypotension

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

Study Arms (2)

Rectus Sheath Block

ACTIVE COMPARATOR

Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) without the addition of clonidine.

Drug: Rectus Sheath Block

Rectus sheath block with clonidine

ACTIVE COMPARATOR

Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with clonidine

Drug: Rectus Sheath Block with Clonidine

Interventions

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.

Also known as: RSB

Rectus Sheath Block

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.

Also known as: RSB with clonidine

Rectus sheath block with clonidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Policlinica Universitária Piquet Carneiro

Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil

RECRUITING

Related Publications (4)

• Cucchiaro G, Ganesh A. The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children. Anesth Analg. 2007 Mar;104(3):532-7. doi: 10.1213/01.ane.0000253548.97479.b8.

  PMID: 17312203 BACKGROUND

• Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Wang J. The Facilitatory Effects of Adjuvant Pharmaceutics to Prolong the Duration of Local Anesthetic for Peripheral Nerve Block: A Systematic Review and Network Meta-analysis. Anesth Analg. 2021 Sep 1;133(3):620-629. doi: 10.1213/ANE.0000000000005640.

  PMID: 34153021 BACKGROUND

• Visoiu M, Scholz S, Malek MM, Carullo PC. The addition of clonidine to ropivacaine in rectus sheath nerve blocks for pediatric patients undergoing laparoscopic appendectomy: A double blinded randomized prospective study. J Clin Anesth. 2021 Aug;71:110254. doi: 10.1016/j.jclinane.2021.110254. Epub 2021 Mar 19.

  PMID: 33752119 BACKGROUND

• Kwon HJ, Kim YJ, Kim Y, Kim S, Cho H, Lee JH, Kim DH, Jeong SM. Complications and Technical Consideration of Ultrasound-Guided Rectus Sheath Blocks: A Retrospective Analysis of 4033 Patients. Anesth Analg. 2023 Feb 1;136(2):365-372. doi: 10.1213/ANE.0000000000006282. Epub 2022 Nov 29.

  PMID: 36638514 BACKGROUND

MeSH Terms

Conditions

Hernia, Umbilical; Pain, Postoperative

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Samuel N Abreu, MD

CONTACT

55 21 987901911; samuel.abreu@ppc.uerj.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a parallel-assignment, randomized, double-blind, controlled clinical trial involving two intervention arms. Eligible adult patients undergoing ambulatory umbilical hernia repair are allocated in a 1:1 ratio to receive either ultrasound-guided rectus sheath block (RSB) with local anesthetics alone (control group) or RSB with local anesthetics plus clonidine (intervention group). Randomization is performed using block randomization with variable block sizes to ensure balance between groups. Allocation is concealed through sealed opaque envelopes. Both participants and outcome assessors are blinded to group assignment.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: January 7, 2025
• Primary Completion: December 16, 2025
• Study Completion: April 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting information will be made available beginning 6 months after publication of the primary results and will remain available for 5 years after publication.
• Access Criteria: Access to the de-identified individual participant data and supporting documents will be granted to qualified researchers upon reasonable request, provided that the proposed use is for scientific research purposes and complies with institutional and ethical guidelines. Requests should be submitted to the corresponding author and will be evaluated by the research team. Data will be shared under a data use agreement.

Locations

BR (1)