Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure
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: Stoma Closure, 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 →
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Official title
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial
Overview
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.
Interventions
- 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
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
- 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.
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: NCT07571902 · E2026079