Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Bilateral PENG Block for Total Vaginal Hysterectomy (PENG)

3. november 2026 oppdatert av: Stephan Cohn, University of Illinois Chicago

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Alexandra Barabanova, MS
  • Telefonnummer: 312-355-5733
  • E-post: barabano@uic.edu

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PENG Block

Following induction of general anesthesia and prior to surgical positioning, participants will receive bilateral ultrasound-guided PENG blocks

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain intensity during the PACU stay
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants requiring rescue opioid analgesia during the PACU stay
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Location of postoperative pain
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

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
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

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
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge
Incidence of postoperative nausea and vomiting during the PACU stay
Tidsramme: Any time during PACU stay
Any time during PACU stay
Duration of PACU stay
Tidsramme: PACU Stay
PACU Stay

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lower-extremity motor weakness following bilateral PENG block, a
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

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
Tidsramme: 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
Tidsramme: The postoperative observation period in PACU
The postoperative observation period in PACU
Signs or symptoms of local anesthetic systemic toxicity
Tidsramme: Starting from the block time until 30 min after the block

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
Tidsramme: 30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

Weakness in lower-extremity and numbness

30 minutes after PACU arrival, 60 minutes after PACU arrival, and at PACU discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Stephan Cohn, MD, University of Illinois Chicago

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2026-1073

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

To avoid breeches of privacy and confidentiality

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere