Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04474873
• Other study ID #: E1-20-315
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2020
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: August 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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/

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Nephrolithotomy, Percutaneous
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• erector 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.	postoperative 24 hours
Primary	Dynamic Visual Analog Scale	the 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	postoperative 24 hours
Primary	Peak Expiratory Flow Rate( PEFR)	maximum speed of expiration as measured with a peak flow meter	postoperative 24 hours
Secondary	Time for first analgesic requirement	Time between end of surgery and patients first analgesic demand	24 hours
Secondary	ambulation time	first postoperative mobilization time of the patient	5 days
Secondary	length of hospital stay	day of hospitalization	1 week
Secondary	Rikert Agitation Scale	postoperative agitation score; unarousable; very sedated; sedated; calm and cooperative; agitated; very agitated; dangerous agitation	24 hours
Secondary	nausea and vomiting	incidence of nausea and vomiting	24 hours
Secondary	patient satisfaction with anesthesia and analgesia	4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)	24 hour
Secondary	starting oral intake	first oral intake	48 hours
Secondary	urinary catheter releated pain score(Visual Analog Scale)	the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.	postoperative 24 hours
Secondary	surgeon satisfaction with anesthesia and analgesia	4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)	24 hour