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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前:Alexandra Barabanova, MS
- 電話番号:312-355-5733
- メール:barabano@uic.edu
研究連絡先のバックアップ
- 名前:Kantarakorn Unchiti, MD PhD
- メール:Kantarakorn.u@gmail.com
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的: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 |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain intensity during the PACU stay
時間枠: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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants requiring rescue opioid analgesia during the PACU stay
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Any time during PACU stay
|
Any time during PACU stay
|
|
|
Duration of PACU stay
時間枠:PACU Stay
|
PACU Stay
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lower-extremity motor weakness following bilateral PENG block, a
時間枠: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
時間枠: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
時間枠:The postoperative observation period in PACU
|
The postoperative observation period in PACU
|
|
|
Signs or symptoms of local anesthetic systemic toxicity
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
捜査官
- 主任研究者:Stephan Cohn, MD、University of Illinois Chicago
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 2026-1073
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
To avoid breeches of privacy and confidentiality
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米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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