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临床试验/NCT07571902
NCT07571902尚未招募不适用

Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial

Sixth Affiliated Hospital, Sun Yat-sen University0 个研究点目标入组 250 人开始时间: 2026年4月27日最近更新:
适应症
干预措施

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

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

No Intervention

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.

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

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangcai Ruan, MD, PhD

Professor

Sixth Affiliated Hospital, Sun Yat-sen University

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