An Early Phase 1 interventional study of PENG Block in Pericapsular Nerve Group Block (PENG Block) and Total Vaginal Hysterectomy, sponsored by University of Illinois Chicago. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Illinois Chicago · Early Phase 1, Interventional, and Treatment
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.
University of Illinois Chicago is the lead sponsor of 20 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Known allergy or 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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following induction of general anesthesia and prior to surgical positioning, participants will receive bilateral ultrasound-guided PENG blocks
Procedure: PENG Block
After negative aspiration and confirmation of appropriate needle position, 20 mL of 0.2% ropivacaine will be administered on each side, for a total volume of 40 mL and a total ropivacaine dose of 80 mg
Postoperative pain intensity during the PACU stay
Assessed using the Numeric Rating Scale (NRS, 0-10) at PACU arrival (once awake and able to provide a reliable assessment).
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Proportion of participants requiring rescue opioid analgesia during the PACU stay
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Location of postoperative pain
Self-reported by the participant at each PACU assessment and categorized as deep pelvic/vaginal, perineal/introital, suprapubic, groin/hip, medial thigh, or lower back pain
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Cutaneous sensory block, at each PACU pain-assessment timepoint
assessed bilaterally in the femoral, saphenous, obturator, lateral femoral cutaneous, genitofemoral (femoral branch), and ilioinguinal/iliohypogastric territories using a 3-point scale
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Correspondence between the anatomical territories in which sensory block is demonstrated and the anatomical location of reported postoperative pain
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Incidence of postoperative nausea and vomiting during the PACU stay
Time frame: Any time during PACU stay
Duration of PACU stay
Time frame: PACU Stay
Lower-extremity motor weakness following bilateral PENG block, a
Assessed bilaterally by knee extension (quadriceps, femoral nerve) and hip adduction (adductors, obturator nerve) and graded using the Medical Research Council (MRC) 0-5 scale, referenced to the participant's own preoperative baseline examination
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Persistence of sensory or motor block at PACU discharge
Defined as any territory scored as reduced or absent, or any MRC grade below the participant's preoperative baseline, at the final PACU assessment
Time frame: PACU discharge
Falls or near-falls
Time frame: The postoperative observation period in PACU
Signs or symptoms of local anesthetic systemic toxicity
Cardiovascular System Symptoms * Early or Moderate Signs: * Blood pressure changes (initial hypertension or rapid tachycardia, progressing to low blood pressure/hypotension) * Slow heart rate (bradycardia) or heart rhythm irregularities (arrhythmias) * Conduction delays and heart blocks * Severe / Life-Threatening Signs: * Ventricular tachycardia or ventricular fibrillation * Cardiac arrest, asystole, or pulseless electrical activity (PEA
Time frame: Starting from the block time until 30 min after the block
New lower-extremity sensory or neurological symptoms following the block
Weakness in lower-extremity and numbness
Time frame: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
No study locations are listed for this record.
Plan to share: No — To avoid breeches of privacy and confidentiality
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University of Illinois Chicago