The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration

Percutaneous Nephrolithotomy Clinical Trial

Official title:

The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration in Patients Undergoing Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764008
• Other study ID #: AUTF ANESTHESIA2
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2016
• Last updated: October 10, 2016
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• chronic pain

• bleeding disorders

• renal or hepatic insufficiency

• patients on chronic non-steroidal anti-inflammatory medications

• emergency cases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

Drug:
• Bupivacaine
20 ml %0,25 bupivacaine

Device:
• Ultrasound

Locations

Country	Name	City	State
Turkey	Ataturk University	Yakutiye	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption		First 24 hours total opioid consumption	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.	postoperative first hour	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.	postoperative second hour	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively	postoperative 4th hour	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively	postoperative 8th hour	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.	postoperative 12th hour	Yes
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively	postoperative 24th hour	Yes