Postoperative Pain, Quality of Recovery, Stoma Closure
Conditions
Keywords
Stoma Closure, Ileostomy Closure, Colostomy Closure, Postoperative Pain, Quality of Recovery, Intercostal Space Block, Paravertebral Nerve Block
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.
Interventions
PROCEDURERevised-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 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean postoperative NRS pain score during the first 2 postoperative days | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Resting and movement NRS pain scores on postoperative days 1 and 2 | 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. |
| Proportion of participants with NRS pain score 4 or greater | 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. |
| Postoperative opioid and analgesic consumption | 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. |
| Postoperative complications | 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. |
| Length of postoperative hospital stay | 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. |
| Patient satisfaction with analgesia | 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). |
Contacts
CONTACTXiangcai Ruan, MD
Outcome results
None listed