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NCT Number: NCT07571902

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure

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.

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Key information

Conditions

Stoma Closure Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Quality of Recovery Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

  2. Mean QoR-15 score on postoperative days 1 and 2

    Time frame: Postoperative day 1 and postoperative day 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.

Secondary outcomes

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

    Time frame: Postoperative day 1 and postoperative day 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.

  2. Proportion of participants with NRS pain score 4 or greater

    Time frame: Postoperative day 1 and postoperative day 2

    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.

  3. Postoperative opioid and analgesic consumption

    Time frame: Postoperative day 1 and postoperative day 2

    Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate.

  4. Postoperative complications

    Time frame: From surgery through postoperative day 30

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

  5. Length of postoperative hospital stay

    Time frame: From surgery through postoperative day 30

    Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.

  6. Patient satisfaction with analgesia

    Time frame: Postoperative day 2

    Patient satisfaction with postoperative analgesia will be assessed using a a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).

Other outcomes

  1. Incidence of local anesthetic systemic toxicity

    Time frame: From intervention through postoperative day 30

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

  2. NRS pain scores at 30 days after surgery

    Time frame: Postoperative day 30

    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).

  3. QoR-15 score at 30 days after surgery

    Time frame: Postoperative day 30

    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).

  4. Morbidity within 30 days after surgery

    Time frame: From surgery through postoperative day 30

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

  5. Readmission within 30 days after surgery

    Time frame: From surgery through postoperative day 30

    Hospital readmission within 30 days after surgery will be recorded and compared between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangcai Ruan, MD

CONTACT

[email protected]

+86 13760710099

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: r-PVB III

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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