Clinical trial NCT04835922: Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL
Official title: Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stone
Keywords: PCNL
Intercostal nerve block
Peritract Infiltration
Bupivacaine
Kidney stone
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study will be prospective double blind randomized trial using 0.25% bupivacaine in patients undergoing PCNL under one of the two arms: Intercostal Nerve block or Peritract Infiltration.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

* Intercostal nerve block and peritract infiltration are common regional analgesic methods used by most of the investigators that had shown to be adequate for postoperative pain control.
* This study may be helpful in providing evidence for a clinical guideline to manage postoperative pain that will eventually help to decrease the morbidity and bring better outcome.

General Objective :

To compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy.

Specific Objective :

* To analyse the demography of the patient \[age, sex, BMI, stone size and laterality, renal function test, stone burden (size, Guy's Stone score etc.)\] undergoing PCNL.
* To compare the intensity of pain using visual analogue score, resting and dynamic VAS scores, following PCNL between two groups (ICNB and PTI).
* To compare the time to first rescue analgesia and total analgesic requirement between both groups.
* To document the complications of both groups.

Research Hypothesis Is Intercostal nerve block more efficacious than peritract infiltration following PCNL in alleviating pain?

Study Variables

* Independent Variables: Age, Sex, BMI, stone location, laterality and size, Guys Stone score (burden), ASA grade, comorbidity, Group I (ICBN), Group P (PTI) nephrostomy tract size (mini vs standard), no of Tracts (single vs multiple), use to tube (tube vs tubeless), length of hospital stay, stone clearance, complications
* Dependent Variables R-VAS score, D-VAS score, Time to first analgesic demand, Total analgesic requirement

Eligibility criteria: Inclusion Criteria:

* All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative Pain Score (VAS score)
timeFrame: up to 24 hours
Secondary outcomes:
measure: Time to First Rescue analgesia
timeFrame: up to 24 hours
measure: Total Analgesic Requiremennt
timeFrame: up to 24-48 hours
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhvan University Teaching Hospital
state: Bagmati
Study officials:
affiliation: HOD, Department of Urology and Kidney Transplant Surgery, TUTH
name: Uttam Sharma, MS Surgery
role: STUDY_CHAIR
References:
citation: Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17.
citation: Singh I, Yadav OK, Gupta S. Efficacy of intercostal nerve block with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Urol Ann. 2019 Oct-Dec;11(4):363-368. doi: 10.4103/UA.UA_141_18.
citation: Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.