Stoma Closurer-PVB IIINCT07571902
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure
A study testing Revised-Paravertebral Nerve Block in people with Stoma Closure and Postoperative Pain, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Closure, Postoperative Pain, Quality of Recovery
- What is being tested?
- Revised-Paravertebral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Stoma Closure, Postoperative Pain, Quality of Recovery
- Being tested
- Revised-Paravertebral Nerve Block
- Keywords
- Stoma Closure, Ileostomy Closure, Colostomy Closure, Postoperative Pain, Quality of Recovery, Intercostal Space Block, Paravertebral Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised-Paravertebral Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Revised-Paravertebral Nerve Block |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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), 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.
Measured: Postoperative day 1 and postoperative day 2
Secondary outcomes (6)
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.
Measured: 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.
Measured: Postoperative day 1 and postoperative day 2
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.
Measured: 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.
Measured: 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.
Measured: From surgery through postoperative day 30
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).
Measured: Postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start27 Apr 2026 (estimated)
- Primary completion27 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma ClosureStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571902
- Sponsor's protocol ID
- E2026079
- Acronym
- r-PVB III
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07571902
- Acronym / sponsor ID
- r-PVB III / E2026079
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 27 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-PVB | Experimental | Procedure: Revised-Paravertebral Nerve BlockParticipants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older.
- Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revised-Paravertebral Nerve BlockParticipants 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. | Procedure or surgery | r-PVB |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Revised-Paravertebral Nerve Block in people with Stoma Closure and Postoperative Pain, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangcai Ruan, MD (+86 13760710099, ruanxc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.