Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2021
CompletedApril 8, 2021
April 1, 2021
1 year
February 20, 2021
April 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Score (VAS score)
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). •
up to 24 hours
Secondary Outcomes (2)
Time to First Rescue analgesia
up to 24 hours
Total Analgesic Requiremennt
up to 24-48 hours
Study Arms (2)
Intercostal Nerve Block
EXPERIMENTAL• 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).
Peritract infiltration
ACTIVE COMPARATORIn 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.
Interventions
: 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)
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).
Eligibility Criteria
You may qualify if:
- All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tribhvan University Teaching Hospital
Kathmandu, Bagmati, 00977, Nepal
Related Publications (3)
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.
PMID: 28890561BACKGROUNDSingh 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.
PMID: 31649454BACKGROUNDChoi 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.
PMID: 29288788RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Uttam Sharma, MS Surgery
HOD, Department of Urology and Kidney Transplant Surgery, TUTH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blinded study : participants and investigator will be blinded using sealed enveloped method.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MS Resident
Study Record Dates
First Submitted
February 20, 2021
First Posted
April 8, 2021
Study Start
November 9, 2020
Primary Completion
November 9, 2021
Study Completion
November 12, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
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.