Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy (REVISED-PVB II)
6 maj 2026 uppdaterad av: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
After laparoscopic cholecystectomy, 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 eighth or ninth intercostal level with the patient kept supine after induction of anesthesia.
Rather than puncturing the classical paraspinal target near the transverse process with a specific prone or lateral position of the patient, r-PVB is designed to exploit medial spread of local anesthetic along the intercostal-endothoracic-extrapleural continuum, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and specific body positioning.
r-PVB 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xiangcai Ruan, MD
- Telefonnummer: +86 13760710099
- E-post: ruanxc@mail.sysu.edu.cn
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Kontrollera
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Experimentell: 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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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean QoR-15 score on postoperative days 1 and 2
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative opioid and analgesic consumption
Tidsram: 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
Tidsram: 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
Tidsram: 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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Proportion of participants with NRS pain score 4 or greater
Tidsram: 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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Resting and movement NRS pain scores on postoperative days 1 and 2
Tidsram: Postoperative day 1 and postoperative day 2
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Resting and movement-related pain will be assessed using the Numeric 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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Patient satisfaction with analgesia
Tidsram: Postoperative day 2
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Patient satisfaction with postoperative analgesia will be assessed using a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
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Postoperative day 2
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of local anesthetic systemic toxicity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
27 april 2026
Primärt slutförande (Beräknad)
27 mars 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
18 april 2026
Först inskickad som uppfyllde QC-kriterierna
27 april 2026
Första postat (Faktisk)
5 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E2026080
Plan för individuella deltagardata (IPD)
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NEJ
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