Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL

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ClinicalTrials.gov Identifier: NCT04835922

Recruitment Status : Recruiting

First Posted : April 8, 2021

Last Update Posted : April 8, 2021

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Sponsor:

Information provided by (Responsible Party):

Dr Sushil Gyawali, Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Stone	Procedure: Intercostal Nerve Block Procedure: Peritract Infiltration	Not Applicable

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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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
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.
Masking:	Double (Participant, Investigator)
Masking Description:	Double blinded study : participants and investigator will be blinded using sealed enveloped method.
Primary Purpose:	Treatment
Official Title:	Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial
Actual Study Start Date :	November 9, 2020
Estimated Primary Completion Date :	November 9, 2021
Estimated Study Completion Date :	November 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Kidney stones

MedlinePlus related topics: Kidney Stones

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intercostal Nerve Block • In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each).	Procedure: Intercostal Nerve Block : Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each) Other Name: Regional anesthesia
Active Comparator: Peritract infiltration In Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing.	Procedure: Peritract Infiltration At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Other Name: Regional anesthesia

Arm

Intervention/treatment

Experimental: Intercostal Nerve Block

• In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each).

Procedure: Intercostal Nerve Block

: Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each)

Other Name: Regional anesthesia

Active Comparator: Peritract infiltration

In Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing.

Procedure: Peritract Infiltration

At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position).

Other Name: Regional anesthesia

Outcome Measures

Primary Outcome Measures :

Postoperative Pain Score (VAS score) [ Time Frame: 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). •

Secondary Outcome Measures :

Time to First Rescue analgesia [ Time Frame: up to 24 hours ]
Pain score will be recorded after the intervention as described earlier. Patients who will have VAS score of > 4 or intractable pain will be given rescue analgesia, that is injection ketorolac intravenously. The usual dose is 30 mg 4-6 hourly by the intravenous route. The time after procedure that patient needs first dose of rescue analgesia i.e Inj Ketorolac will be recorded. Dosage will be adjusted according to pain severity and response.
Total Analgesic Requiremennt [ Time Frame: up to 24-48 hours ]
Total Analgesia requirement of Inj Ketorolac required by the patient for the first 24 hours up to the discharge will be added up and recorded along with the time given.

Eligibility Criteria

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Ages Eligible for Study:	17 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835922

Contacts

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Contact: Sushil Gyawali, MS Resident	+9779849742715	drsushilgyawali@gmail.com
Contact: Bhojraj Luitel, MCh Urology	+9779851222344	drbhojraj@gmail.com

Locations

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Nepal
Tribhvan University Teaching Hospital	Recruiting
Kathmandu, Bagmati, Nepal, 00977
Contact: Sushil Gyawali, MS Resident +9779849742715 drsushilgyawali@gmail.com
Contact: Bhojraj Luitel, MCh Urology +9779851222344 drbhojraj@gmail.com
Sub-Investigator: Bhojraj Luitel, MCh Urology
Principal Investigator: Sushil Gyawali, MS Resident
Sub-Investigator: Amit Sharma Bhattarai, MD Anesthesia
Sub-Investigator: Uttam Sharma, MS Surgery

Sponsors and Collaborators

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Investigators

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Study Chair:	Uttam Sharma, MS Surgery	HOD, Department of Urology and Kidney Transplant Surgery, TUTH

More Information

Additional Information:

choi et al , Pubmed article, PCNL This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Other Publications:

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.

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.

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Responsible Party:	Dr Sushil Gyawali, MS Resident, Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier:	NCT04835922
Other Study ID Numbers:	615-2020 REF/2021/01/000059 ( Registry Identifier: NHRC trial registry number )
First Posted:	April 8, 2021 Key Record Dates
Last Update Posted:	April 8, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	After the research is completed, results will be published as Original Article in Journal. Relevant Individual data will be published in Journal itself as a part of the article.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Dr Sushil Gyawali, Tribhuvan University Teaching Hospital, Institute Of Medicine.:


PCNL Intercostal nerve block Peritract Infiltration Bupivacaine Kidney stone

Additional relevant MeSH terms:

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Kidney Calculi Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi	Calculi Pathological Conditions, Anatomical Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

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