Bilateral PENG Block for Total Vaginal Hysterectomy (PENG)

Bilateral Ultrasound-Guided Pericapsular Nerve Group (PENG) Block for Postoperative Analgesia After Total Vaginal Hysterectomy Under General Anesthesia: A Prospective Exploratory Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Vaginal Hysterectomy; Pericapsular Nerve Group Block (PENG Block)
• Intervention / Treatment: Procedure: PENG Block

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Alexandra Barabanova, MS; Phone Number: 312-355-5733; Email: barabano@uic.edu
• Study Contact Backup: Name: Kantarakorn Unchiti, MD PhD; Email: Kantarakorn.u@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG Block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants requiring rescue opioid analgesia during the PACU stay		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	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	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		30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Incidence of postoperative nausea and vomiting during the PACU stay		Any time during PACU stay
Duration of PACU stay		PACU Stay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	PACU discharge
Falls or near-falls		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	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	30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

Collaborators and Investigators

• Sponsor: University of Illinois Chicago
• Investigators: Principal Investigator: Stephan Cohn, MD, University of Illinois Chicago

Publications and helpful links

General Publications

• Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.
• Pai P, Amor D, Lai YH, Echevarria GC. Use and Clinical Relevancy of Pericapsular Nerve Block (PENG) in Total Hip Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2024 May 1;40(5):320-332. doi: 10.1097/AJP.0000000000001196.
• ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818.
• Huang Y, Lu Y, Wang J, Lu Q, Bao HF, Liu L, Dong CS. Effect of Pericapsular Nerve Group Block with Different Concentrations and Volumes of Ropivacaine on Functional Recovery in Total Hip Arthroplasty: A Randomized, Observer-Masked, Controlled Trial. J Pain Res. 2024 Feb 14;17:677-685. doi: 10.2147/JPR.S445000. eCollection 2024.
• Wegmann T. [Detection and treatment of rabies in humans]. Schweiz Med Wochenschr. 1966 Jun 11;96(23):743-6. No abstract available. German.
• Hin PC. Laparoscopic-assisted gastrostomy in 26 patients: indications and outcome at 2 years. J Laparoendosc Surg. 1996 Feb;6(1):25-8. doi: 10.1089/lps.1996.6.25.
• Slopnick EA, Sears SB, Chapman GC, Sheyn DD, Abrams MK, Roberts KM, Pollard R, Mangel J. Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial. Urogynecology (Phila). 2023 Oct 1;29(10):827-835. doi: 10.1097/SPV.0000000000001351. Epub 2023 Apr 4.
• Goidescu OC, Dogaru IA, Badea TG, Enyedi M, Enciu O, Gheoca Mutu DE, Filipoiu FM. The distribution of the inferior hypogastric plexus in female pelvis. J Med Life. 2022 Jun;15(6):784-791. doi: 10.25122/jml-2022-0145.
• Hartmann F. [75th Anniversary of professor Dr. Rudolf Schoen]. Med Klin. 1967 Feb 24;62(8):314-6. No abstract available. German.
• Aurore V, Rothlisberger R, Boemke N, Hlushchuk R, Bangerter H, Bergmann M, Imboden S, Mueller MD, Eppler E, Djonov V. Anatomy of the female pelvic nerves: a macroscopic study of the hypogastric plexus and their relations and variations. J Anat. 2020 Sep;237(3):487-494. doi: 10.1111/joa.13206. Epub 2020 May 19.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Pericapsular Nerve Group Block (PENG Block); Total Vaginal Hysterectomy
• Other Study ID Numbers: 2026-1073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

To avoid breeches of privacy and confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes