Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure (r-PVB III)
6. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xiangcai Ruan, MD
- Telefonnummer: +86 13760710099
- E-post: ruanxc@mail.sysu.edu.cn
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
|
|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean QoR-15 score on postoperative days 1 and 2
Tidsramme: Postoperative day 1 and postoperative day 2
|
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.
|
Postoperative day 1 and postoperative day 2
|
|
Mean postoperative NRS pain score during the first 2 postoperative days
Tidsramme: From discharge from the post-anesthesia care unit through postoperative day 2.
|
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.
|
From discharge from the post-anesthesia care unit through postoperative day 2.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative opioid and analgesic consumption
Tidsramme: Postoperative day 1 and postoperative day 2
|
Postoperative opioid and other analgesic consumption will be recorded and compared between groups.
Opioid use will be converted to oral morphine equivalents where appropriate.
|
Postoperative day 1 and postoperative day 2
|
|
Postoperative complications
Tidsramme: From surgery through postoperative day 30
|
Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
Length of postoperative hospital stay
Tidsramme: From surgery through postoperative day 30
|
Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
|
From surgery through postoperative day 30
|
|
Resting and movement NRS pain scores on postoperative days 1 and 2
Tidsramme: Postoperative day 1 and postoperative day 2
|
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.
|
Postoperative day 1 and postoperative day 2
|
|
Proportion of participants with NRS pain score 4 or greater
Tidsramme: Postoperative day 1 and postoperative day 2
|
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.
|
Postoperative day 1 and postoperative day 2
|
|
Patient satisfaction with analgesia
Tidsramme: Postoperative day 2
|
Patient satisfaction with postoperative analgesia will be assessed using a a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
|
Postoperative day 2
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of local anesthetic systemic toxicity
Tidsramme: From intervention through postoperative day 30
|
The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
|
From intervention through postoperative day 30
|
|
Morbidity within 30 days after surgery
Tidsramme: From surgery through postoperative day 30
|
Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
Readmission within 30 days after surgery
Tidsramme: From surgery through postoperative day 30
|
Hospital readmission within 30 days after surgery will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
QoR-15 score at 30 days after surgery
Tidsramme: Postoperative day 30
|
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).
|
Postoperative day 30
|
|
NRS pain scores at 30 days after surgery
Tidsramme: Postoperative day 30
|
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).
|
Postoperative day 30
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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)
27. april 2026
Primær fullføring (Antatt)
27. mars 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E2026079
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .