The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Low thoracic paravertebral block T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine |
Drug: Bupivacaine
20 ml %0,25 bupivacaine
Device: Ultrasound
|
| Active Comparator: Peritubal infiltration Peritubal infiltration with 20 ml %0,25 bupivacaine |
Drug: Bupivacaine
20 ml %0,25 bupivacaine
|
| No Intervention: Control Group No drug |
Outcome Measures
Primary Outcome Measures
- Opioid consumption [First 24 hours total opioid consumption]
Secondary Outcome Measures
- Visual analog pain score [postoperative first hour]
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.
- Visual analog pain score [postoperative second hour]
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.
- Visual analog pain score [postoperative 4th hour]
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
- Visual analog pain score [postoperative 8th hour]
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
- Visual analog pain score [postoperative 12th hour]
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.
- Visual analog pain score [postoperative 24th hour]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ataturk University | Yakutiye | Erzurum | Turkey | 25100 |
Sponsors and Collaborators
- Ataturk University
Investigators
- Study Director: Ali Ahiskalioglu, Ass.Prof., Ataturk University Anesthesiology and Reanimation
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- AUTF ANESTHESIA2