NCT02764008

Brief Summary

Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients. Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure. Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management. Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space. The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy. Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

May 4, 2016

Last Update Submit

October 10, 2016

Conditions

Percutaneous Nephrolithotomy

Keywords

Postoperative AnalgesiaPeritubal infiltrationUltrasound guided low thoracic paravertebral blockPercutaneous Nephrolithotomy pain

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    First 24 hours total opioid consumption

Secondary Outcomes (6)

  • Visual analog pain score

    postoperative first hour

  • Visual analog pain score

    postoperative second hour

  • Visual analog pain score

    postoperative 4th hour

  • Visual analog pain score

    postoperative 8th hour

  • Visual analog pain score

    postoperative 12th hour

  • +1 more secondary outcomes

Study Arms (3)

Low thoracic paravertebral block

ACTIVE COMPARATOR

T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine

Drug: BupivacaineDevice: Ultrasound

Peritubal infiltration

ACTIVE COMPARATOR

Peritubal infiltration with 20 ml %0,25 bupivacaine

Drug: Bupivacaine

Control Group

NO INTERVENTION

No drug

Interventions

BupivacaineDRUG

20 ml %0,25 bupivacaine

Low thoracic paravertebral blockPeritubal infiltration
UltrasoundDEVICE
Low thoracic paravertebral block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy

You may not qualify if:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Yakutiye, Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Kirac M, Tepeler A, Bozkurt OF, Elbir F, Ozluk C, Armagan A, Unsal A, Biri H. The efficacy of bupivacaine infiltration on the nephrostomy tract in tubeless and standard percutaneous nephrolithotomy: a prospective, randomized, multicenter study. Urology. 2013 Sep;82(3):526-31. doi: 10.1016/j.urology.2013.02.083. Epub 2013 Jul 4.

    PMID: 23831069BACKGROUND

  • Ak K, Gursoy S, Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gokce G, Mimaroglu C. Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patients: a randomized controlled clinical trial. Med Princ Pract. 2013;22(3):229-33. doi: 10.1159/000345381. Epub 2012 Dec 14.

    PMID: 23257888BACKGROUND

MeSH Terms

Interventions

BupivacaineUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ali Ahiskalioglu, Ass.Prof.

    Ataturk University Anesthesiology and Reanimation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

TU(1)