Skip to main content
OpenTrials
Completed

NCT Number: NCT03454139

Subcostal TAP Block For Percutaneous Nephrolithotomy

Percutaneous nephrolithotomy (PCNL) is a minimally- invasive procedure for removing kidney stones. The small incision of PCNL is performed medially from the posterior axillary line according to stones location. Despite the small skin incision patients suffer from postoperative pain due to visceral pain and intercostal nerve injury. The aim of this study is to evaluate the perioperative analgesic effect of subcostal transversus abdominis plane (TAP) block performed prior to PCNL procedure.

Primary outcome of our study was Morphine consumption at 48th hour after the surgery. Secondary outcomes were perioperative fentanyl consumption; postoperative Verbal Analog Scale and additional analgesic drug requirement.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients who were scheduled for elective percutaneous nephrolithotomy were randomized into two groups: Group TAP and Group IV. General anesthesia was induced with propofol 2 mg/kg, fentanyl 1 mcgr/kg and rocuronium 0,6 mg/kg and maintained with sevoflurane 2% in 40%:60% oxygen/air mixture and fentanyl 0,5 mcgr/kg and rocuronium 10 mg, if necessary. Unilateral Transversus abdominis plane block was performed with total of 30 ml volume of local anesthetic solution (20ml Bupivacaine 0,125% and 10ml Lidocaine 1%) after intubation but before surgery to the Group TAP patients. Paracetamol 1 gr, iv was given to the Group IV 20 minutes before the end of the surgery. Also 100mg Tramadol,iv was administered 20 minutes before the end of the surgery to the both groups. Morphine iv patient controlled analgesia was applied to both groups. Perioperative fentanyl consumption; postoperative Verbal Analog Scale, morphine consumption and additional analgesic drug requirement were determined. Data of perioperative complications and adverse effects were also collected. Chi square with Yates correction and Mann Whitney U tests were used for statistical analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients enrolled for percutaneous nephrolithotomy (PCNL) surgery
  • ASA (American Society of Anesthesiologists) score I-III

Exclusion criteria

  • patients with chronic pain
  • patients on opioid or other analgesic drugs
  • BMI (body mass index) higher than 40
  • allergies for drugs used in the study
  • chronic renal failure receiving dialysis

Treatment and study plan

Subcostal Transversus Abdominis Plane Block

Procedure

Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,5 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia.

Primary outcomes

  1. Total morphine used (milligram)

    Time frame: 48 hours after the end of the surgery

    Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.

Secondary outcomes

  1. Morphine consumption (milligram)

    Time frame: 1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

    Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.

  2. Additional analgesic requirement

    Time frame: 1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

    Additional analgesia regimen is planned as (in order of administration): 1000 mg/100ml Paracetamol iv infusion; 50 mg Dexketoprofen trometamol iv; 100mg Tramadol iv infusion. Additional analgesia is administrated when VAS is equal to or higher than 4.

  3. Visual Analog Scale (VAS)

    Time frame: 1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

    Patients are asked to rate their pain according to 10 point VAS in which 0 means "no pain at all" , 10 means "worst pain ever".

  4. Fentanyl consumption (microgram/kg)

    Time frame: 0 minute after the end of the surgery

    Fentanyl 1 microgram/kg is administered at anesthesia induction. Fentanyl 0,5 microgram/kg is added during the surgery, if needed (20% increasing of heart rate or mean blood pressure)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

A Comparison of Perioperative Analgesic Effects of Preemptive Subcostal Transversus Abdominis Plane (TAP) Block and Paracetamol for Percutaneous Nephrolithotomy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.