Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Mean postoperative NRS pain score during the first 2 postoperative days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
排除标准
- •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.
研究组 & 干预措施
Control
r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
干预措施: Revised-Paravertebral Nerve Block (Procedure)
结局指标
主要结局
Mean postoperative NRS pain score during the first 2 postoperative days
时间窗: 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
时间窗: 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.
次要结局
- Postoperative opioid and analgesic consumption(Postoperative day 1 and postoperative day 2)
- Postoperative complications(From surgery through postoperative day 30)
- Length of postoperative hospital stay(From surgery through postoperative day 30)
- Resting and movement NRS pain scores on postoperative days 1 and 2(Postoperative day 1 and postoperative day 2)
- Proportion of participants with NRS pain score 4 or greater(Postoperative day 1 and postoperative day 2)
- Patient satisfaction with analgesia(Postoperative day 2)
研究者
Xiangcai Ruan, MD, PhD
Professor
Sixth Affiliated Hospital, Sun Yat-sen University
