Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure

NCT07571902 | Not Yet Recruiting

• 1 other identifier: E2026079
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stoma Closure; Postoperative Pain; Quality of Recovery

Keywords

Stoma Closure; Ileostomy Closure; Colostomy Closure; Postoperative Pain; Quality of Recovery; Intercostal Space Block; Paravertebral Nerve 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

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.

r-PVB

Eligibility Criteria

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

You may qualify if:

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

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.
• 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.

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 27, 2026
• First Posted: May 6, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share