Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy

NCT07566819 | Not Yet Recruiting

• 1 other identifier: E2026080
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Gallbladder Disease; Laparoscopic Cholecystectomy; Postoperative Pain; Quality of Recovery

Keywords

Laparoscopic Cholecystectomy; Postoperative Pain; Quality of Recovery; Paravertebral Nerve Block; intercostal space block

Outcome Measures

Primary Outcomes (2)

• Mean postoperative NRS pain score during the first 2 postoperative days

  Postoperative pain will be assessed using the Numerical Rating Scale (NRS, 0-10). 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.

• 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; range 0-150). 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

Secondary Outcomes (6)

• Resting and movement NRS pain scores on postoperative days 1 and 2

  Postoperative day 1 and postoperative day 2

• Proportion of participants with NRS pain score 4 or greater

  Postoperative day 1 and postoperative day 2

• Postoperative opioid and analgesic consumption

  Postoperative day 1 and postoperative day 2

• Postoperative complications

  From surgery through postoperative day 30

• Length of postoperative hospital stay

  From surgery through postoperative day 30

Other Outcomes (5)

• Incidence of local anesthetic systemic toxicity

  From intervention through postoperative day 30

• NRS pain scores at 30 days after surgery

  Postoperative day 30

• QoR-15 score at 30 days after surgery

  Postoperative day 30

Study Arms (2)

r-PVB

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Revised-Paravertebral Nerve Block PROCEDURE

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.

r-PVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Xiangcai Ruan, MD

CONTACT

+86 13760710099; ruanxc@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 5, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share