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临床试验/CTRI/2025/02/081339
CTRI/2025/02/081339尚未招募不适用

Quality Of Recovery In Patients Undergoing Percutaneous Nephrolithotomy Under Opioid Free General Anaesthesia With Erector Spinae Block :A Prospective Observational Study

Dr Kotla Likith1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年3月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To observe and calculate the post operative quality of recovery score in patients undergoing pcnl surgery with opioid free anaesthesia plus regional block using QOR-15 questionnaire

研究概览

简要总结

INTRODUCTION AND BACKGROUND OF THE PROPOSED PROJECT

Percutaneous nephrolithotomy (PCNL) is a very common surgical technique used for the treatment of renal stones. During PCNL,

postoperative pain is a complex condition that needs a multimodal approach and good pain management.It can decrease hospital stay,

rate of complications, and decrease overall health cost. Conventional postoperative pain management with opioids compromise early

recovery and discharge due to their side effects. Thus, the multimodal postoperative pain management approach helps in reducing

opioid-related side effects.[1]

Opioid analgesics are a cornerstone for providing perioperative analgesia. They suppress the neuro-endocrine response during

surgery, and this helps to maintain stable intraoperative hemodynamics. However, perioperative use of opioid analgesics has deleterious

side effects such as respiratory depression, nausea, vomiting, urinary retention,gastrointestinal dysfunction, delirium, pruritus, and last

but not least opioid addiction.

[2]

In a recent study, 12% of surgeries had some kind of opioid-related adverse events.[3]These adverse

effects can lead not only to prolonged hospital admissions, but to unplanned hospital admission, dependence, addiction, hyper-algesia,

and the development of chronic pain as well . Patients with opioid-related adverse events can have nearly twice the treatment costs,

double the length of stay, and significantly higher readmissions to the hospital . [4]

Most of the patients undergoing PCNL have compromised renal function. Nonsteroidal anti-inflammatory drugs (NSAIDs), which

provide excellent opioid-free analgesia is relatively contraindicated in such conditions, hence any technique or drug that can avoid side

effects of opioids and complications of NSAIDs is desirable.[5][6]

Opioid free anesthesia (OFA) is a multimodal procedure combining non-opioid drugs with or without regional anesthesia techniques

that allow a better quality of anesthesia and patient satisfaction.[7]The simultaneous use of non-opioid analgesic drugs

(eg,Dexmedetomidine, magnesium sulfate, xylocaine, and acetaminophen) can have a synergistic effect that improves postoperative

analgesia and prevents opioid-related adverse effects (nausea, vomiting, ileus, sedation, and respiratory Depression) while facilitating

early movement. OFA can fulfil the implementation of enhanced recovery after surgery (ERAS) protocols designed for rapid recovery

after major operations, supporting organ function, and decreasing stress response caused by surgical trauma.[8][9][10]

Erector Spinae Plane Block (ESPB) was first described in 2016 by Forero et al, as a regional anesthetic technique. Local anesthetic

injected into this erector spinae fascial plane spreads in a craniocaudal fashion over several levels and to the paravertebral space, thereby

targeting the dorsal and ventral rami of the spinal nerve. Thus, it can provide both somatic and visceral sensory blockade, making it an

ideal regional anesthetic technique for abdominal and thoracic surgeries.

[11][12]

Quality of recovery (QOR) after anesthesia is an important measure of the early postoperative health status of patients. It incorporates

five dimensions of health: patient support, comfort, emotions, physical independence, and pain. Post operative recovery is an important

parameter in determining discharge in this group of patients. QOR 15 provides a valid, reliable, extensive and efficient evaluation of

patients quality of recovery after anaesthesia and surgery[15]

Hence we are undertaking this observational study to assess the quality of recovery in patients undergoing PCNL surgery with OFA

plus regional block.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients presenting for percutaneous nephrolithotomy surgeries in the age group of 18-60 yrs in which general anaesthesia with Opioid free anaesthesia plus regional block was given.

排除标准

  • patients not giving consent, sensitivity to local anaesthetics, history of drug abuse,use of chronic pain medications.

结局指标

主要结局

To observe and calculate the post operative quality of recovery score in patients undergoing pcnl surgery with opioid free anaesthesia plus regional block using QOR-15 questionnaire

时间窗: Post 24 hrs from surgery

次要结局

  • Post operative pain score(Post operative nausea and vomiting)

研究者

发起方
Dr Kotla Likith
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr Kotla Likith

Lokamanya Tilak Municipal Medical College and Hospital

研究点 (1)

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