Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Revised-Paravertebral Nerve Block
Procedure/SurgeryParticipants 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: r-PVBExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From discharge from the post-anesthesia care unit through postoperative day 2.2
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.
Time frame
Postoperative day 1 and postoperative day 2Secondary outcomes
1
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.
Time frame
Postoperative day 1 and postoperative day 22
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.
Time frame
Postoperative day 1 and postoperative day 23
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.
Time frame
Postoperative day 1 and postoperative day 24
Postoperative complications
Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
Time frame
From surgery through postoperative day 30Other outcomes
1
Incidence of local anesthetic systemic toxicity
The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
Time frame
From intervention through postoperative day 302
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).
Time frame
Postoperative day 303
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).
Time frame
Postoperative day 304
Morbidity within 30 days after surgery
Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
Time frame
From surgery through postoperative day 30Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: