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临床试验/CTRI/2025/04/084029
CTRI/2025/04/084029尚未招募2/3 期

Comparison of ultrasound guided erector spinae plane block and local infiltration of incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy - Randomized Controlled Trial.

NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Nagpur1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Comparison of Ultrasound guided Erector Spinae Plane Block and local anesthetic infiltration of the incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy

研究概览

简要总结

Percutaneous Nephrolithotomy (PCNL) is a minimally invasive surgical technique used to remove renal stones which are either difficult to reach or large or numerous or too dense to be removed by any other method.

It offers less morbidity, shorter hospital stays and early recovery after surgery.

Pain after PCNL is caused by dilatation of the renal capsule and the parenchymal tract and from incision of the skin, subcutaneous tissue, muscle layer and the presence of nephrostomy tube.

Intense post operative pain also relates to postoperative complications including pulmonary dysfunction**.**

NSAIDS can cause severe side effects in these patients with pre existing kidney disease. Therefore they are not preferred.

Loco-regional pain management techniques available for postoperative analgesia provides good pain control.

Post operative analgesia can also be provided by opioids. However, opioids have certain side effects such as nausea, vomiting, itching, respiratory depression etc.

Other regional techniques such as subcutaneous infiltration, peri tubal infiltration, nephrostomy tract infiltration can be invasive.

Local anesthetic infiltration at the site of incision does not provide adequate analgesia thereby increasing the duration of hospital stay.

Erector spinae plane block(ESPB) is a novel technique that is being used nowadays for providing postoperative analgesia in patients undergoing Percutaneous Nephrolithotomy (PCNL) surgery.

It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes at the level of T10, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.

This blockage of the dorsal and ventral rami of the spinal nerves helps to achieve a multi-dermatomal sensory block of the anterior, posterior, and lateral thoracic and abdominal walls.

The main sources of acute pain after PCNL are visceral pain originating from the kidneys and ureters and somatic pain from the incision site. Renal pain is conducted through the T10–L1 spinal nerves, and ureter pain is conducted through T10–L2.

Moreover, cutaneous innervation of the incision site is predominantly supplied by T10–T11 (T8–T12) because the incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space, or in the subcostal area.

There are limited studies to evidence the benefits of ESPB compared to local anesthetic with respect to postoperative analgesic effect for patients undergoing PCNL surgeries.

The aim of our study is to evaluate the efficacy of ESPB compared to local anesthetic for providing effective postoperative analgesia, requirement of rescue analgesics as well as to record any complications appearing within 24 hours of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing PCNL surgery under general anesthesia.
  • Patients satisfying American Society of Anesthesiologists Class 1 and
  • Patients with BMI less than 35.

排除标准

  • Patients not willing to give consent.
  • Patients with spinal deformity.
  • Eg: Kyphoscoliosis Patients with sensitivity to local anesthetics.
  • Contraindications to peripheral nerve blocks.

结局指标

主要结局

Comparison of Ultrasound guided Erector Spinae Plane Block and local anesthetic infiltration of the incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy

时间窗: Numeric Rating Scale. | Time of first rescue analgesia. | Total number of rescue analgesics required in 24 hours.

次要结局

  • Comparison of Ultrasound guided Erector Spinae Plane Block and local anesthetic infiltration of the incision site for post operative analgesia in patients undergoing percutaneous nephrolithotomy in terms of occurrence of any postoperative complications(Nausea)

研究者

发起方
NKP Salve Institute of Medical Sceinces and Research Center and Lata Mangeshkar Hospital, Nagpur
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Samruddhi Homkar

NKPSIMS and Lata Mangeshkar Hospital, Nagpur

研究点 (1)

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