Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure (r-PVB III)

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial

After stoma closure, 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 ninth to eleventh intercostal level with the patient kept supine after induction of anesthesia. Rather than puncturing the classical paraspinal target near the transverse process with the patient in a prone or lateral position, the r-PVB technique is designed to exploit retrograde spread of local anesthetic from the intercostal space to the paravertebral space, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and the need for specific body positioning. The r-PVB technique 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; Quality of Recovery; Stoma Closure
• 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:

• Adults aged 18 years or older.
• Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.

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.
• Expected operative time longer than 150 minutes, or stoma reversal not being the primary surgical procedure.
• Chronic opioid use.
• Heart failure, liver failure, renal failure, coagulation disorders, or a history of allergy to local anesthetics.
• Inability to comply with study procedures, including severe psychiatric illness, refusal to sign informed consent, or anticipated difficulty in completing 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; Participants assigned to the intervention group will receive an ultrasound-guided revised paravertebral block (r-PVB) after induction of general anesthesia and before surgical incision. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe is placed at the mid-axillary line to identify the ninth to eleventh intercostal space on the operative side, together with the pleura and intercostal muscle layers. Using an in-plane technique, the block needle is advanced under real-time ultrasound guidance into the plane of the internal intercostal muscle. Correct needle tip placement is confirmed by small test injections producing characteristic pleural displacement on ultrasound. After confirmation, 30 mL of 0.5% ropivacaine is injected into the target plane to achieve a functional paravertebral block. Routine surgery then proceeds.

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
Resting and movement NRS pain scores on postoperative days 1 and 2	Resting and movement-related pain will be assessed using the Numerical Rating ScaletheNumeric 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
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
Patient satisfaction with analgesia	Patient satisfaction with postoperative analgesia will be assessed using a 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 27, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 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; Paravertebral Nerve Block; Stoma Closure; Ileostomy Closure; Colostomy Closure; 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: E2026079

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