Back to results

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

Primary Purpose

Kidney Stone, Surgery

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

4mg PF Dexamethasone

Control Test

About this trial

This is an interventional other trial for Kidney Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Methodist University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

ANES Block

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

Number of Narcotic administrations post-operatively

Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive

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

Number of complications peri and post-operatively

Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay

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.

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)

Full Information

NCT ID

NCT04663269

First Posted

November 20, 2020

Last Updated

April 21, 2021

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT04663269

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.

Study Start Date

February 24, 2020 (Actual)

Primary Completion Date

September 11, 2020 (Actual)

Study Completion Date

September 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Stone, Surgery

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Anesthesia will know the randomization assignment. The surgeon and the patient will be blinded to randomization.

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Other

Arm Description

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

Arm Title

ANES Block

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

4mg PF Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Control Test

Other Intervention Name(s)

Standard of Care

Intervention Description

Peritubal block - standard local analgesic administration

Primary Outcome Measure Information:

Title

Overnight Admission Rate

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Narcotic for Analgesia post-operatively

Description

Comparison of the percentage of patients in Groups 1 and 2 who require any narcotic for analgesia during the postoperative course following PCNL.

Time Frame

14 days post-op

Title

Proportion of patients with Emergency Department return or re-admission

Description

Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge.

Time Frame

14 days

Title

Number of Narcotic administrations post-operatively

Description

Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive

Time Frame

14 days

Title

Number of Morphine Equivalents post-operatively

Description

Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents

Time Frame

14 days

Title

Number of complications peri and post-operatively

Description

Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay

Time Frame

24 hours

Title

Pain Score

Description

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.

Time Frame

24 hours

Title

Rate of Adjunct Analgesics Post-operatively

Description

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Large, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Methodist University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19397429

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.

Results Reference

background

PubMed Identifier

22096280

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.

Results Reference

background

PubMed Identifier

24173546

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.

Results Reference

background

PubMed Identifier

23445266

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.

Results Reference

background

PubMed Identifier

28850954

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.

Results Reference

background

PubMed Identifier

28890561

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.

Results Reference

background

PubMed Identifier

29454333

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.

Results Reference

background

PubMed Identifier

28525509

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.

Results Reference

background

PubMed Identifier

28635359

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.

Results Reference

background

PubMed Identifier

15273542

Citation

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.

Results Reference

background

PubMed Identifier

18929686

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.

Results Reference

background

PubMed Identifier

17574053

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs