Clinical trial NCT02764008: The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration
Official title: The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration in Patients Undergoing Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Percutaneous Nephrolithotomy
Keywords: Postoperative Analgesia
Peritubal infiltration
Ultrasound guided low thoracic paravertebral block
Percutaneous Nephrolithotomy pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 60
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: First 24 hours total opioid consumption
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first hour
measure: Visual analog pain score
timeFrame: postoperative second hour
measure: Visual analog pain score
timeFrame: postoperative 4th hour
measure: Visual analog pain score
timeFrame: postoperative 8th hour
measure: Visual analog pain score
timeFrame: postoperative 12th hour
measure: Visual analog pain score
timeFrame: postoperative 24th hour
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Ataturk University
state: Erzurum
Study officials:
affiliation: Ataturk University Anesthesiology and Reanimation
name: Ali Ahiskalioglu, Ass.Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.