Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy (REVISED-PVB II)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Laparoscopic Cholecystectomy; Quality of Recovery; Benign Gallbladder Disease
• Intervention / Treatment: Procedure: Revised-Paravertebral Nerve Block

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangcai Ruan, MD; Phone Number: +86 13760710099; Email: ruanxc@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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.	Procedure: Revised-Paravertebral Nerve Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean QoR-15 score on postoperative days 1 and 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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid and analgesic consumption	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	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	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
Proportion of participants with NRS pain score 4 or greater	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
Resting and movement NRS pain scores on postoperative days 1 and 2	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.	Postoperative day 1 and postoperative day 2
Patient satisfaction with analgesia	Patient satisfaction with postoperative analgesia will be assessed using a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).	Postoperative day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of local anesthetic systemic toxicity	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2026
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Quality of Recovery; Laparoscopic Cholecystectomy; Paravertebral Nerve Block; intercostal space block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: E2026080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No