Subcostal TAP Block For Percutaneous Nephrolithotomy

Nephrolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454139
• Other study ID #: 186
• Status: Completed
• Phase: N/A
• First received: February 12, 2018
• Last updated: March 12, 2018
• Start date: October 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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