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Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04474873
Enrollment
3
Registered
2020-07-17
Start date
2020-03-01
Completion date
2020-08-30
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erector Spinae Plane Block, Nephrolithotomy, Percutaneous, Postoperative Pain

Brief summary

This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Detailed description

Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL. Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

Interventions

PROCEDUREerector spinae block

we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing PNL between 18-65 years old

Exclusion criteria

* serious cardiac, respiratory, hepatic, renal or haemotologic disease * mental disorder and hearing problem * anxiety, depression and / or other psychiatric disorders * pregnancy * refusal of patient * Allergy or contraindications to drugs used in the study * ASA \> 2 Inflammation or infection over injection site Obese patients BMI ≥35/

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scalepostoperative 24 hoursthe amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Dynamic Visual Analog Scalepostoperative 24 hoursthe amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
Peak Expiratory Flow Rate( PEFR)postoperative 24 hoursmaximum speed of expiration as measured with a peak flow meter

Secondary

MeasureTime frameDescription
Rikert Agitation Scale24 hourspostoperative agitation score 1. unarousable 2. very sedated 3. sedated 4. calm and cooperative 5. agitated 6. very agitated 7. dangerous agitation
nausea and vomiting24 hoursincidence of nausea and vomiting
patient satisfaction with anesthesia and analgesia24 hour4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
Time for first analgesic requirement24 hoursTime between end of surgery and patients first analgesic demand
urinary catheter releated pain score(Visual Analog Scale)postoperative 24 hoursthe amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
surgeon satisfaction with anesthesia and analgesia24 hour4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)
starting oral intake48 hoursfirst oral intake
ambulation time5 daysfirst postoperative mobilization time of the patient
length of hospital stay1 weekday of hospitalization

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026