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Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy

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ClinicalTrials.gov Identifier: NCT03581539
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Michael Backfish-White, Indiana University

Brief Summary:

All three methods of postoperative analgesia have been shown to decrease postoperative pain control in nephrectomy patients, the three methods have never been compared to each other.

This study aims to compare three different pain techniques proven to be beneficial in surgical nephrectomies, including the efficacy and the side effects of each technique.


Condition or disease Intervention/treatment Phase
Nephrectomy Procedure: Transverses Abdominis Plane (TAP) block Procedure: Quadratus Lumborum (QL) block Procedure: Surgeon Infiltration using Exparel Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients randomized to four-quadrant Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block or surgeon infiltration using Exparel for postoperative analgesia after laparoscopic nephrectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Prospective, Study Comparing Four-quadrant Transverses Abdominis Plane (TAP) Block, Quadratus Lumborum (QL) Block and Surgeon Infiltration Using Exparel for Postoperative Analgesia After Laparoscopic Nephrectomy
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : May 22, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Active Comparator: Group #1
Transverses Abdominis Plane (TAP) block
Procedure: Transverses Abdominis Plane (TAP) block
TAP block - Participants will get an injection of bupivacaine and exparel (numbing medicine) in the four different locations of your stomach. To be more specific, the injection placed between your oblique muscles in four different locations right after you are asleep and just before the start of surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.

Active Comparator: Group #2
Quadratus Lumborum (QL) block
Procedure: Quadratus Lumborum (QL) block
QL block - Participants will get an injection of bupivacaine with exparel (numbing medicine) in two locations in your lower stomach. To be more specific, an injection will take place inside your quadratus lumborum muscle which is slightly deeper than your oblique muscles right after you are asleep and right before surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.

Active Comparator: Group #3
Surgeon Infiltration using Exparel
Procedure: Surgeon Infiltration using Exparel
SI group - at the end of the surgery and just prior to you waking up, the surgeon will use a needle to inject the surgical incision site with bupivacaine and exparel (numbing medicine) spreading the medicine evenly as the needle is slowly withdrawn to make sure all layers are evenly filled with the medicine that will numb the area.




Primary Outcome Measures :
  1. Primary endpoint of this study will be VAS pain score at 24 hours [ Time Frame: Pain scores will be measured 24 hours after surgery ]
    The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  2. Primary endpoint of this study will be VAS pain score at 48 hours [ Time Frame: Pain scores will be measured 48 hours after surgery ]
    Pain scores will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain


Secondary Outcome Measures :
  1. Secondary endpoint includes total IV and PO (By Mouth) opioid consumption at 72 hours [ Time Frame: Opioid consumption will be measured at 1 hour post op, 24, 48, and 72 hours post op. The total amount will be recorded ]
    Opioid consumption will be collected by a study team member post-operatively up to 3 days per protocol time requirements


Other Outcome Measures:
  1. Average Nausea scores over 72 hours [ Time Frame: Nausea scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged ]
    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate or severe

  2. Average Sedation scores over 72 hours [ Time Frame: Sedation scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged ]
    Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake and alert, quietly awake, asleep and arousable, or deep sleep

  3. Subjects overall satisfaction scores [ Time Frame: Post operatively at hour 24 ]
    Subjects will be followed up to 24 hours post operatively by a study team member to document patient overall satisfaction scores

  4. Subjects overall satisfaction scores [ Time Frame: Post operatively at hour 48 ]
    Subjects will be followed up to 48 hours post operatively by a study team member



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic nephrectomy including partial, simple and radical nephrectomy
  • ASA class 1, 2, 3 or 4
  • Age 18 or older, male or female

Exclusion Criteria:

  • Any contraindication for TAP block, QL block or surgeon infiltration
  • Donor Nephrectomy
  • History of substance abuse in the past 6 months
  • Patients on more than 30mg po morphine equivalents of opioids, staff anesthesiologist will confirm this portion prior to enrollment.
  • Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy to bupivacaine or Exparel
  • Patients <40kg or >110 kg TBW

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581539


Contacts
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Contact: Kevin M Backfish-White, MD 317-944-4338 kmbackfi@iupui.edu
Contact: Angie M Plummer, LPN 317-944-7239 plummera@iupui.edu

Locations
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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kevin M Backfish-White, MD    317-944-4338    kmbackfi@iupui.edu   
Contact: Angie m Plummer, LPN CCRP    317-274-0277    plummera@iupui.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Kevin M Backfish-White, MD Indiana University School of Medicine

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Responsible Party: Kevin Michael Backfish-White, Anesthesiologist, Indiana University
ClinicalTrials.gov Identifier: NCT03581539     History of Changes
Other Study ID Numbers: 1801979369
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Michael Backfish-White, Indiana University:
Laparoscopic Nephrectomy,
Simple Nephrectomy
Partial Nephrectomy
Pain,acute
Pain,postoperative