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

NCT04835922 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

  • Kidney Stone

Interventions

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)

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).

Sponsors & Collaborators

  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    lead OTHER

Principal Investigators

  • Uttam Sharma, MS Surgery · HOD, Department of Urology and Kidney Transplant Surgery, TUTH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-11-09
Completion
2021-11-12

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835922 on ClinicalTrials.gov