Subcostal TAP Block For Percutaneous Nephrolithotomy

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

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis
• Intervention / Treatment: Procedure: Subcostal transversus abdominis plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subcostal TAP group; 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 %0,25 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia. After that, the patient is positioned to lithotomy position and the open-end catheter is inserted. After that the patient is turned to prone position and the percutaneous nephrolithotomy is performed. Tramadol 100 mg iv is administrated 20 minutes before the end of the surgery. Morphine patient controlled analgesia is planned for postoperative pain management.	Procedure: Subcostal transversus abdominis plane block; 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.
No Intervention: Non- TAP group; Percutaneous nephrolithotomy is performed under general anesthesia. No regional analgesia is administered to this patients. Paracetamol 1000 mg/100ml; iv and Tramadol 100mg iv is administered 20 minutes before the end of the surgery for postoperative analgesia. Morphine patient controlled analgesia is planned for postoperative pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine used (milligram)	Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.	48 hours after the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption (milligram)	Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.	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 analgesic requirement	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.	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
Visual Analog Scale (VAS)	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".	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
Fentanyl consumption (microgram/kg)	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)	0 minute after the end of the surgery

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: pain; lidocaine; morphine; bupivacaine; percutaneous nephrolithotomy; subcostal transversus abdominis plane block; paracetamol; tramadol; nephrolithiasis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 186

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No