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Not Yet Recruiting NCT07925411

Bilateral PENG Block for Total Vaginal Hysterectomy

Conditions: Pericapsular Nerve Group Block (PENG Block), Total Vaginal Hysterectomy

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 30
Sponsor: University of Illinois Chicago

Summary

This prospective, single-arm pilot study will evaluate the feasibility, safety, and preliminary analgesic outcomes of bilateral pericapsular nerve group (PENG) blocks in adult patients undergoing total vaginal hysterectomy (TVH) under general anesthesia at UI Health. The study will target 25 evaluable subjects, with enrollment of up to 30 subjects to account for withdrawal or incomplete data. Following induction of general anesthesia, subjects will receive ultrasound-guided bilateral PENG blocks using 20 mL of 0.2% ropivacaine per side, in addition to standard perioperative analgesic management. Outcomes will include postoperative pain scores, perioperative analgesic requirements, motor weakness and ambulation, postoperative nausea and vomiting, PACU recovery and discharge, and adverse events. Data from this pilot study will be used to characterize the feasibility and safety of the intervention and to inform the design of a future controlled study.

Eligibility Criteria

Inclusion Criteria: 1. Age 18 years or older 2. Scheduled to undergo elective total vaginal hysterectomy under general anesthesia 3. Planned postoperative recovery in the PACU 4. Able to provide written informed consent 5. Able to understand and report postoperative pain using the NRS (0-10) Exclusion Criteria: Known allergy or hypersensitivity to the local anesthetic selected for the PENG block or to other amide local anesthetics 2\. Infection, cellulitis, open wound, or other active skin or soft-tissue infection at or near the proposed block site 3\. Known clinically significant coagulopathy, thrombocytopenia, or anticoagulant or antiplatelet therapy that, according to institutional guidelines or the judgment of the treating anesthesiologist, would increase the risk associated with performance of the PENG block 4\. Pre-existing clinically significant lower-extremity neurologic or motor deficit that may increase the risk associated with the block or interfere with postoperative assessment of motor or neurologic adverse events 5\. Anatomical abnormality, prior surgery involving the proposed block region, or other condition that, in the judgment of the treating anesthesiologist, would prevent adequate visualization of relevant anatomy or safe performance of the PENG block 6\. Any medical condition or clinical circumstance that, in the judgment of the treating anesthesiologist or investigator, would increase the risk associated with bilateral PENG block or administration of the study local anesthetic 7\. Planned neuraxial anesthesia or another regional anesthetic technique expected to provide perioperative analgesia and interfere with assessment of the study intervention 8\. Receipt or planned receipt of additional local anesthetic that would result in a total local anesthetic dose considered unsafe by the treating anesthesiologist 9\. Inability to reliably communicate postoperative pain using the NRS 10\. Pregnancy 11\. Prisoner status

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07925411). StuddyBuddy aggregates publicly available trial information.