- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07567950
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy (r-PVB-1)
5. maj 2026 opdateret af: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.
Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery.
Under ultrasound guidance, an intercostal space between the 6th and 8th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
Traditional Paravertebral Nerve Block (PVB) is performed right after the lateral positioning of surgery under ultrasound guidance.
According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches.
Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the 6th and 8th transverse processes, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space.
Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement.
Stop advancing the needle when the tip passes through the superior costotransverse ligament.
Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura.
Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine.
The fluid movement and pleura depression observed on ultrasound confirm proper needle placement.
Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB.
The surgical procedure will start right after the intervention blocks.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiangcai Ruan, MD
- Telefonnummer: +86 13760710099
- E-mail: ruanxc@mail.sysu.edu.cn
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases
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
- Surgeon-estimated high likelihood of conversion to open surgery
- Chronic opioid use
- Heart failure, liver failure, or renal failure
- Coagulation disorders
- History of allergy to local anesthetics
- Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery.
Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
|
|
Andet: PVB
Control
|
Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance.
According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches.
Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space.
Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement.
Stop advancing the needle when the tip passes through the superior costotransverse ligament.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean postoperative NRS pain score during the first 2 postoperative days
Tidsramme: From post-anesthesia care unit through postoperative day 2
|
Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).
|
From post-anesthesia care unit through postoperative day 2
|
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
|
Patient satisfaction with analgesia
Tidsramme: Postoperative day 2
|
Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.
|
Postoperative day 2
|
|
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 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 pain score 4 or greater
Tidsramme: Postoperative day 1 and postoperative day 2
|
The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.
|
Postoperative day 1 and postoperative day 2
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
|
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 Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
6. maj 2026
Primær færdiggørelse (Anslået)
30. april 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
28. april 2026
Først indsendt, der opfyldte QC-kriterier
28. april 2026
Først opslået (Faktiske)
5. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E2026081
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