search
Back to results

Subcostal TAP Block For Percutaneous Nephrolithotomy

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subcostal transversus abdominis plane block
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring percutaneous nephrolithotomy, subcostal transversus abdominis plane block, pain, paracetamol, tramadol, morphine, nephrolithiasis, lidocaine, bupivacaine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Subcostal TAP group

    Non- TAP group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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".
    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)

    Full Information

    First Posted
    February 12, 2018
    Last Updated
    March 12, 2018
    Sponsor
    Istanbul University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03454139
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nephrolithiasis
    Keywords
    percutaneous nephrolithotomy, subcostal transversus abdominis plane block, pain, paracetamol, tramadol, morphine, nephrolithiasis, lidocaine, bupivacaine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subcostal TAP group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Non- TAP group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Subcostal transversus abdominis plane block
    Intervention Description
    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 Outcome Measure Information:
    Title
    Total morphine used (milligram)
    Description
    Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.
    Time Frame
    48 hours after the end of the surgery
    Secondary Outcome Measure Information:
    Title
    Morphine consumption (milligram)
    Description
    Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.
    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
    Title
    Additional analgesic requirement
    Description
    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.
    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
    Title
    Visual Analog Scale (VAS)
    Description
    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".
    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
    Title
    Fentanyl consumption (microgram/kg)
    Description
    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)
    Time Frame
    0 minute after the end of the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Subcostal TAP Block For Percutaneous Nephrolithotomy

    We'll reach out to this number within 24 hrs