Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Revised-Paravertebral Nerve Block

    Procedure/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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: r-PVBExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From discharge from the post-anesthesia care unit through postoperative day 2.
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), 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.

Time frame
Postoperative day 1 and postoperative day 2

Secondary outcomes

1

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.

Time frame
Postoperative day 1 and postoperative day 2
2

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.

Time frame
Postoperative day 1 and postoperative day 2
3

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.

Time frame
Postoperative day 1 and postoperative day 2
4

Postoperative complications

Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.

Time frame
From surgery through postoperative day 30

Other outcomes

1

Incidence of local anesthetic systemic toxicity

The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.

Time frame
From intervention through postoperative day 30
2

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).

Time frame
Postoperative day 30
3

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).

Time frame
Postoperative day 30
4

Morbidity within 30 days after surgery

Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.

Time frame
From surgery through postoperative day 30

Locations

This trial has no locations.

Sponsors and contacts

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