Regional Erector Spinae Analgesic Block vs Standard of Care Undergoing Percutaneous Nephrolithotomy

NCT04663269 | Terminated Phase 4 FDA Drug

• 1 other identifier: 87943342
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if adding a spinal block (medicine that will numb parts of the body to block pain) along with standard pain control at the incision site will decrease the need for narcotics for pain management and decrease the percentage of patients requiring hospital admission for pain control during postoperative , in-hospital, care after a percutaneous nephrolithotomy (PCNL) (surgery to remove kidney stones), commonly called PERC.

Conditions

Kidney Stone; Surgery

Outcome Measures

Primary Outcomes (1)

• Overnight Admission Rate

  Percentage of patients in Groups 1 and 2 who require overnight admission to the hospital for pain control postoperatively (i.e. patients unable to be discharged to home from the postoperative anesthesia care unit PACU).

  24 hours

Secondary Outcomes (7)

• Narcotic for Analgesia post-operatively

  14 days post-op

• Proportion of patients with Emergency Department return or re-admission

  14 days

• Number of Narcotic administrations post-operatively

  14 days

• Number of Morphine Equivalents post-operatively

  14 days

• Number of complications peri and post-operatively

  24 hours

Study Arms (2)

Control

OTHER

Standard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block

Drug: Control Test

ANES Block

EXPERIMENTAL

Patients randomized to the erector spinae block (Group 2) will have the block placed in the preoperative area by the anesthesia team. 0-4 mg midazolam and/or 0-100 mcg of fentanyl may be provided prior to and in order to place the block itself. The local anesthetic will diffuse to involve the dorsal and ventral rami of the spinal nerves, achieving a sensory block of the affected area. The erector spinae block analgesic will be administered by the anesthesia team. The analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone.

Drug: 4mg PF Dexamethasone

Interventions

4mg PF Dexamethasone DRUG

analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone

ANES Block

Control Test DRUG

Peritubal block - standard local analgesic administration

Also known as: Standard of Care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years Undergoing unilateral or bilateral PCNL for treatment of kidney stones Estimated glomerular filtration rate \> 30 mL/min. PCNL is planned as an outpatient procedure with no overnight hospital stay

You may not qualify if:

• Inability to provide informed consent Pregnancy Patients having any additional simultaneous procedures other than a contralateral PCNL,(including contralateral treatment of kidney stones with a non-PCNL operation such as ureteroscopy) Patients with a documented neurologic injury that reduces pain sensation to the back Patients with an existing pain disorder Patients with an existing narcotics agreement due to current or prior narcotic abuse Patients with a documented allergy to a narcotic or NSAID analgesic BMI \> 35 Patients who require more than 1 site of percutaneous access into the kidney to adequately complete the PCNL (this is a judgment made preoperatively at the initial clinic patient encounter)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Methodist University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (12)

• Jonnavithula N, Pisapati MV, Durga P, Krishnamurthy V, Chilumu R, Reddy B. Efficacy of peritubal local anesthetic infiltration in alleviating postoperative pain in percutaneous nephrolithotomy. J Endourol. 2009 May;23(5):857-60. doi: 10.1089/end.2008.0634.

  PMID: 19397429 BACKGROUND

• Parikh GP, Shah VR, Modi MP, Chauhan NC. The analgesic efficacy of peritubal infiltration of 0.25% bupivacaine in percutaneous nephrolithotomy - A prospective randomized study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):481-4. doi: 10.4103/0970-9185.86591.

  PMID: 22096280 BACKGROUND

• Ozkan D, Akkaya T, Karakoyunlu N, Arik E, Ergil J, Koc Z, Gumus H, Ersoy H. Effect of ultrasound-guided intercostal nerve block on postoperative pain after percutaneous nephrolithotomy : prospective randomized controlled study. Anaesthesist. 2013 Dec;62(12):988-94. doi: 10.1007/s00101-013-2253-z. Epub 2013 Nov 1.

  PMID: 24173546 BACKGROUND

• Honey RJ, Ghiculete D, Ray AA, Pace KT. A randomized, double-blinded, placebo-controlled trial of intercostal nerve block after percutaneous nephrolithotomy. J Endourol. 2013 Apr;27(4):415-9. doi: 10.1089/end.2012.0418.

  PMID: 23445266 BACKGROUND

• Yang H, Yu X, Hu J, Peng E, Li C, Cui L, Zhao C, Wang S, Wei C, Mei W, Wang S, Ye Z. Usage of Multilevel Paravertebral Block as the Main Anesthesia for Mini-Invasive PCNL: Retrospective Review of 45 Cases with Large Stones. Urol Int. 2017;99(3):326-330. doi: 10.1159/000480094. Epub 2017 Aug 30.

  PMID: 28850954 BACKGROUND

• 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: 28890561 BACKGROUND

• Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.

  PMID: 29454333 BACKGROUND

• Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113.

  PMID: 28525509 BACKGROUND

• Yeying G, Liyong Y, Yuebo C, Yu Z, Guangao Y, Weihu M, Liujun Z. Thoracic paravertebral block versus intravenous patient-controlled analgesia for pain treatment in patients with multiple rib fractures. J Int Med Res. 2017 Dec;45(6):2085-2091. doi: 10.1177/0300060517710068. Epub 2017 Jun 21.

  PMID: 28635359 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Miller NL, Matlaga BR, Lingeman JE. Techniques for fluoroscopic percutaneous renal access. J Urol. 2007 Jul;178(1):15-23. doi: 10.1016/j.juro.2007.03.014. Epub 2007 May 11.

  PMID: 17574053 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tim Large, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Anesthesia will know the randomization assignment. The surgeon and the patient will be blinded to randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 10, 2020
• Study Start: February 24, 2020
• Primary Completion: September 11, 2020
• Study Completion: September 24, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)