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.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Alexandra Barabanova, MS
- Telefonnummer: 312-355-5733
- E-post: barabano@uic.edu
Studer Kontakt Backup
- Navn: Kantarakorn Unchiti, MD PhD
- E-post: Kantarakorn.u@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Scheduled to undergo elective total vaginal hysterectomy under general anesthesia
- Planned postoperative recovery in the PACU
- Able to provide written informed consent
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / 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
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
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
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
|
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
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: Stephan Cohn, MD, University of Illinois Chicago
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
Andre studie-ID-numre
- 2026-1073
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
To avoid breeches of privacy and confidentiality
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