Clinical trial NCT03454139: Subcostal TAP Block For Percutaneous Nephrolithotomy
Official title: A Comparison of Perioperative Analgesic Effects of Preemptive Subcostal Transversus Abdominis Plane (TAP) Block and Paracetamol for Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Keywords: percutaneous nephrolithotomy
subcostal transversus abdominis plane block
pain
paracetamol
tramadol
morphine
nephrolithiasis
lidocaine
bupivacaine
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine used (milligram)
timeFrame: 48 hours after the end of the surgery
Secondary outcomes:
measure: Morphine consumption (milligram)
timeFrame: 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
measure: Additional analgesic requirement
timeFrame: 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
measure: Visual Analog Scale (VAS)
timeFrame: 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
measure: Fentanyl consumption (microgram/kg)
timeFrame: 0 minute after the end of the surgery
Other outcomes:
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