The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration

Phase 4

Completed

• Conditions: Percutaneous Nephrolithotomy
• Interventions: Drug: Bupivacaine; Device: Ultrasound

• Registration Number: NCT02764008
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low thoracic paravertebral block	Ultrasound	T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine
Low thoracic paravertebral block	Bupivacaine	T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine
Peritubal infiltration	Bupivacaine	Peritubal infiltration with 20 ml %0,25 bupivacaine

Primary Outcome Measures

Name	Time	Method
Opioid consumption	First 24 hours total opioid consumption

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Yakutiye, Erzurum, Turkey