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Not yet recruiting NCT07566819

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy

No phase Interventional Benign Gallbladder Disease Laparoscopic Cholecystectomy Postoperative Pain Quality of Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Revised-Paravertebral Nerve Block.
Who it may be relevant to
Registry conditions: Benign Gallbladder Disease, Laparoscopic Cholecystectomy, Postoperative Pain, Quality of Recovery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Mean postoperative NRS pain score during the first 2 postoperative days [Time frame: From discharge from the post-anesthesia care unit through postoperative day 2.]
  • Mean QoR-15 score on postoperative days 1 and 2 [Time frame: Postoperative day 1 and postoperative day 2]
Secondary outcome measures (6)
  • Resting and movement NRS pain scores on postoperative days 1 and 2 [Time frame: Postoperative day 1 and postoperative day 2]
  • Proportion of participants with NRS pain score 4 or greater [Time frame: Postoperative day 1 and postoperative day 2]
  • Postoperative opioid and analgesic consumption [Time frame: Postoperative day 1 and postoperative day 2]
  • Postoperative complications [Time frame: From surgery through postoperative day 30]
  • Length of postoperative hospital stay [Time frame: From surgery through postoperative day 30]
  • Patient satisfaction with analgesia [Time frame: Postoperative day 2]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07566819 · E2026080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗