Clinical trial NCT04474873: Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?
Official title: SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Nephrolithotomy, Percutaneous
Erector Spinae Plane Block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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/

Primary outcomes:
measure: Visual Analog Scale
timeFrame: postoperative 24 hours
measure: Dynamic Visual Analog Scale
timeFrame: postoperative 24 hours
measure: Peak Expiratory Flow Rate( PEFR)
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Time for first analgesic requirement
timeFrame: 24 hours
measure: ambulation time
timeFrame: 5 days
measure: length of hospital stay
timeFrame: 1 week
measure: Rikert Agitation Scale
timeFrame: 24 hours
measure: nausea and vomiting
timeFrame: 24 hours
measure: patient satisfaction with anesthesia and analgesia
timeFrame: 24 hour
measure: starting oral intake
timeFrame: 48 hours
measure: urinary catheter releated pain score(Visual Analog Scale)
timeFrame: postoperative 24 hours
measure: surgeon satisfaction with anesthesia and analgesia
timeFrame: 24 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Anesthesiology Department
name: Semih Baskan, 2
role: STUDY_DIRECTOR
References:
citation: Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.