Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure (r-PVB III)
6 mei 2026 bijgewerkt door: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial
After stoma closure, pain remains an important problem affecting patient recovery.
A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary ninth to eleventh intercostal level with the patient kept supine after induction of anesthesia.
Rather than puncturing the classical paraspinal target near the transverse process with the patient in a prone or lateral position, the r-PVB technique is designed to exploit retrograde spread of local anesthetic from the intercostal space to the paravertebral space, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and the need for specific body positioning.
The r-PVB technique addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
250
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xiangcai Ruan, MD
- Telefoonnummer: +86 13760710099
- E-mail: ruanxc@mail.sysu.edu.cn
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
Exclusion Criteria:
- Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥8), sepsis, or allergy to local anesthetics.
- Expected operative time longer than 150 minutes, or stoma reversal not being the primary surgical procedure.
- Chronic opioid use.
- Heart failure, liver failure, renal failure, coagulation disorders, or a history of allergy to local anesthetics.
- Inability to comply with study procedures, including severe psychiatric illness, refusal to sign informed consent, or anticipated difficulty in completing postoperative follow-up.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Controle
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Experimenteel: r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
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Participants assigned to the intervention group will receive an ultrasound-guided revised paravertebral block (r-PVB) after induction of general anesthesia and before surgical incision.
With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe is placed at the mid-axillary line to identify the ninth to eleventh intercostal space on the operative side, together with the pleura and intercostal muscle layers.
Using an in-plane technique, the block needle is advanced under real-time ultrasound guidance into the plane of the internal intercostal muscle.
Correct needle tip placement is confirmed by small test injections producing characteristic pleural displacement on ultrasound.
After confirmation, 30 mL of 0.5% ropivacaine is injected into the target plane to achieve a functional paravertebral block.
Routine surgery then proceeds.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean QoR-15 score on postoperative days 1 and 2
Tijdsspanne: Postoperative day 1 and postoperative day 2
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Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.
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Postoperative day 1 and postoperative day 2
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Mean postoperative NRS pain score during the first 2 postoperative days
Tijdsspanne: From discharge from the post-anesthesia care unit through postoperative day 2.
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Postoperative pain will be assessed using theNumeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).The primary pain outcome is the mean of eight postoperative NRS pain scores assessed upon discharge from the post-anesthesia care unit; on the evening of surgery between 7:00 PM and 9:00 PM; and on postoperative days 1 and 2, in the morning between 6:00 AM and 10:00 AM, at midday between 12:00 PM and 3:00 PM, and in the evening between 7:00 PM and 9:00 PM.
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From discharge from the post-anesthesia care unit through postoperative day 2.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative opioid and analgesic consumption
Tijdsspanne: Postoperative day 1 and postoperative day 2
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Postoperative opioid and other analgesic consumption will be recorded and compared between groups.
Opioid use will be converted to oral morphine equivalents where appropriate.
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Postoperative day 1 and postoperative day 2
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Postoperative complications
Tijdsspanne: From surgery through postoperative day 30
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Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
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From surgery through postoperative day 30
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Length of postoperative hospital stay
Tijdsspanne: From surgery through postoperative day 30
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Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
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From surgery through postoperative day 30
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Resting and movement NRS pain scores on postoperative days 1 and 2
Tijdsspanne: Postoperative day 1 and postoperative day 2
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Resting and movement-related pain will be assessed using the Numerical Rating ScaletheNumeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
at predefined time points on postoperative days 1 and 2.
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Postoperative day 1 and postoperative day 2
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Proportion of participants with NRS pain score 4 or greater
Tijdsspanne: Postoperative day 1 and postoperative day 2
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The proportion of participants with clinically significant pain, defined as an Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), score of 4 or greater, will be compared between groups.
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Postoperative day 1 and postoperative day 2
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Patient satisfaction with analgesia
Tijdsspanne: Postoperative day 2
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Patient satisfaction with postoperative analgesia will be assessed using a a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
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Postoperative day 2
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of local anesthetic systemic toxicity
Tijdsspanne: From intervention through postoperative day 30
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The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
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From intervention through postoperative day 30
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Morbidity within 30 days after surgery
Tijdsspanne: From surgery through postoperative day 30
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Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
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From surgery through postoperative day 30
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Readmission within 30 days after surgery
Tijdsspanne: From surgery through postoperative day 30
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Hospital readmission within 30 days after surgery will be recorded and compared between groups.
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From surgery through postoperative day 30
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QoR-15 score at 30 days after surgery
Tijdsspanne: Postoperative day 30
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Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
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Postoperative day 30
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NRS pain scores at 30 days after surgery
Tijdsspanne: Postoperative day 30
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Resting and movement-related pain at 30 days after surgery will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
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Postoperative day 30
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
27 april 2026
Primaire voltooiing (Geschat)
27 maart 2027
Studie voltooiing (Geschat)
31 december 2027
Studieregistratiedata
Eerst ingediend
27 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
6 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E2026079
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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