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

Surgery Clinical Trial

Official title:

Randomized, Prospective Trial of Regional Erector Spinae Analgesic Block Versus Standard of Care in Patients Undergoing Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04663269
• Other study ID #: 87943342
• Status: Terminated
• Phase: Phase 4
• Start date: February 24, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: April 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 24, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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)

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Surgery

Intervention

Drug:
• 4mg PF Dexamethasone
analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone
• Control Test
Peritubal block - standard local analgesic administration

Locations

Country	Name	City	State
United States	Methodist University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Miller NL, Matlaga BR, Lingeman JE. Techniques for fluoroscopic percutaneous renal access. J Urol. 2007 Jul;178(1):15-23. Epub 2007 May 11. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Narcotic for Analgesia post-operatively	Comparison of the percentage of patients in Groups 1 and 2 who require any narcotic for analgesia during the postoperative course following PCNL.	14 days post-op
Secondary	Proportion of patients with Emergency Department return or re-admission	Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge.	14 days
Secondary	Number of Narcotic administrations post-operatively	Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive	14 days
Secondary	Number of Morphine Equivalents post-operatively	Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents	14 days
Secondary	Number of complications peri and post-operatively	Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay	24 hours
Secondary	Pain Score	Maximum patient reported pain score within the first 24 hours post operatively using 0-10 numeric pain intensity scale (NPIS) where 0 is no pain, 5 is moderate pain and 10 is the worst possible pain.	24 hours
Secondary	Rate of Adjunct Analgesics Post-operatively	Nonsteroidal Anti-inflammatories; Y/N; If Yes, name & dose; If Yes, total # of times administered; If Yes total # of times administered/(LOS in hours/24); Gabbapentinoids; Y/N; If Yes, name & dose; If Yes, total # of times administered; If Yes total # of times administered/(LOS in hours/24); Acetaminophen; Y/N; If Yes, name & dose; If Yes, total # of times administered; If Yes total # of times administered/(LOS in hours/24)	14 days