Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative Pain Score (VAS score)
研究概览
简要总结
Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. To lower the morbidity of PCNL, proper and adequate management of postoperative pain remains an integral component of PCNL.
There are many ways to reduce the postoperative pain following PCNL including mini PCNL, tubeless PCNL, use of regional analgesia etc. However the modality of analgesic technique is still a matter of debate. The aim of this study is to evaluate the efficacy of intercostal nerve block compared with peritract infiltration in patient undergoing PCNL. Specifically, the study will look on to the demography of patients undergoing PCNL and their indications. The study will also compare the intensity of pain in two groups using visual analogue scale (VAS). The study will be a prospective double blinded randomized clinical trial done at Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching hospital (TUTH). The time frame of this study will be of 1 year or when sample size is fulfilled including all the patients who visit the hospital for PCNL and fulfils the inclusion criteria. At the end of our study we expect to conclude that the use of intercostal nerve block is superior or inferior than or equal to peritract infiltration in alleviating the postoperative pain following PCNL.
详细描述
Introduction:
The incidence and prevalence of renal calculi have increased globally across all ages, sex, and race, probably due to change in dietary habits and global warming. PCNL is considered 'gold standard' for the management of large renal calculi because it is less invasive and morbid than the open surgery. Currently, the indications for PCNL include large size renal calculi (>1.5-2 cm), staghorn calculi, upper tract calculi not responding to other modalities of treatment, lower pole stones, cystine nephrolithiasis, and stones in anatomically abnormal kidneys. However, the procedure causes postoperative pain, mostly due to dilatation of the renal capsule, the parenchyma and pain along the tract of the nephrostomy tube. So the postoperative pain remains an integral part of management. Postoperative pain management not only reduces patient suffering but also improve patient satisfaction, reduces morbidity and in parallel enhances recovery, improves rehabilitation, reduces hospital stay and thereby overall hospital cost. The postoperative pain due to the procedure may vary with individual pain perception, use of percutaneous nephrostomy (PCN) tubes, comorbid conditions, choice of analgesic route, anesthetic agents and postoperative course. Small calibers of tubes, even mini PCNL or tubeless PCNL and regional analgesia such as intercostal nerve block, peritract infiltration, paravertebral block etc. could further decrease postoperative pain and analgesic requirement and hence improving postoperative patient comfort. However, studies on these techniques have produced conflicting results due to the use of different local anesthetics, various regional techniques, and different study designs. So this study aims to compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in alleviating postoperative pain following the procedure with the subjective assessment of pain
Rational/justification :
• The optimal method of pain control after percutaneous nephrolithotomy remains controversial till now.
We need better technique of analgesia to decrease the pain following PCNL.
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, Investigator)
盲法说明
Double blinded study : participants and investigator will be blinded using sealed enveloped method.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital.
排除标准
- •Patient ≤16 years of age, known history of hypersensitivity/anaphylaxis/ contraindications to bupivacaine, Systemic Diseases (CKD, active UTI, untreated sepsis), Relook surgery, high ASA grade ( >2) unfit for anesthesia/PCNL , Contraindications for PCNL (pregnancy, coagulopathy) , Patients who decline to participate
结局指标
主要结局
Postoperative Pain Score (VAS score)
时间窗: up to 24 hours
Patients undergoing PCNL who fulfil the inclusion criteria will be identified at the time of admission. • Patients will be randomized in two groups using sealed envelope method into ICNB (group I) and PTI (group P) prior to surgery. After the procedure (intervention) the intensity of pain will be evaluated by an independent observer (the researcher or an independent ward nurse) blinded to the allocated groups at postoperative 2, 8, 12 and 24 hours. The pain score will be assessed separately by Visual Analogue Scale (VAS), a 10-point scale ranging from 0, minimum or no pain, to 10, the maximum pain score perceived or imagined by the patient, at rest (RVAS) and on deep breathing or coughing known as dynamic VAS (DVAS). •
次要结局
- Total Analgesic Requiremennt(up to 24-48 hours)
- Time to First Rescue analgesia(up to 24 hours)
研究者
Dr Sushil Gyawali
MS Resident
Tribhuvan University Teaching Hospital, Institute Of Medicine.