Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Nephrectomy
• Intervention / Treatment: Procedure: Transverses Abdominis Plane (TAP) block; Procedure: Quadratus Lumborum (QL) block; Procedure: Surgeon Infiltration using Exparel

Detailed Description

Both four-quadrant TAP block and QL blocks will be done after induction of anesthesia but prior to incision. Surgeon infiltration will be completed intraoperatively at the end of the surgery. All procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.

All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively per SOC. Patients above 70 years will receive 300 mg gabapentin per SOC. Patients will be grouped by type of nephrectomy: simple, radical, or partial. Patients will be randomized to type of block. Intraoperatively, the patient will receive ketamine 0.5 mg/kg LBM at the beginning of the case followed by a 0.25 mg/kg/hr infusion during surgery but turned off prior to emergence per SOC; patients with relative contraindications to ketamine such as history of seizures may not receive ketamine and this will NOT be considered a deviation.

For group 1, the TAP block group, after the patient is induced, the skin will be prepped with ChloPrep and a clean, sterile transducer will be placed in an axial (transverse) plane to visualize the TAP plane just superior to the iliac crest. This will allow us to identify the three muscular layers of the abdominal wall: the external oblique (most superficial), the internal oblique, and the transversus abdominis. Using an in-plane technique (seeing the needle at all times), the needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance and 15 mL 0.125% bupivacaine plus 5 mL of Exparel® will be injected into the fascial plane; this procedure will be repeated in the other four quadrants of the abdomen. The tip of the needle will be observed under ultrasound at all times, making this a minimal risk procedure. It is also important to note that the mg dose of bupivacaine with exparel will never be in a ratio greater than 1:2 per Exparel dosing guidelines. A total of 80 mL will be given.

The QL block will be performed after induction with the patient placed in a slight lateral position in order to facilitate visualization of the Quadratus Lumborum muscle. Once the skin has been prepped and the sterile transducer is applied, the continuation of the transversalis fascia will be visualized along with the termination of the external and internal obliques. The quadratus lumborum will be identified deep to these structures. Once identified, an in plane technique will be used in order to place the needle in the plane just superior to the QL and 20 mL of 0.125% bupivacaine along with 10mL of Exparel will be injected. The same process will be repeated on the contralateral side. Once again the needle will be visualized throughout the procedure.

Surgeon infiltration will be completed at the end of the procedure before the patient emerges from general anesthesia. The needle will be inserted approximately 0.5 to 1 cm into the tissue plane to ensure that all layers of the surgical incision are infiltrated. The local anesthetic solution of 5 mL 0.125% bupivacaine plus 10 mL Exparel® will be injected while slowly withdrawing the needle to decrease the risk of intravascular injection.22 A total of 30 mL will be delivered. Surgeon name will be recorded.

All patients will be scheduled on PO acetaminophen and PO gabapentin daily postoperatively per SOC. PO oxycodone or tramadol PRN per SOC will be started once patients are tolerating a diet. PRN IV dilaudid, fentanyl, or morphine will also be given for severe breakthrough pain per SOC.

Opioid usage at 1, 24, 48 and 72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Investigators will record postoperative time of 1st flatus. Patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded. First liquid and first food intake will also be recorded.

All patients will receive a phone call approximately two weeks after surgery for assessment for patient satisfaction and pain scores. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score, opiate usage, and activity of daily living. Study participation will conclude after the two week follow-up and the questionnaire has been completed.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin M Backfish-White, MD; Phone Number: 317-944-4338; Email: kmbackfi@iupui.edu
• Study Contact Backup: Name: Angie M Plummer, LPN; Phone Number: 317-944-7239; Email: plummera@iupui.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint of this study will be VAS pain score at 24 hours	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	Pain scores will be measured 24 hours after surgery
Primary endpoint of this study will be VAS pain score at 48 hours	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	Pain scores will be measured 48 hours after surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Nausea scores over 72 hours	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	Nausea scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged
Average Sedation scores over 72 hours	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	Sedation scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged
Subjects overall satisfaction scores	Subjects will be followed up to 24 hours post operatively by a study team member to document patient overall satisfaction scores	Post operatively at hour 24
Subjects overall satisfaction scores	Subjects will be followed up to 48 hours post operatively by a study team member	Post operatively at hour 48

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Kevin M Backfish-White, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): November 17, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic Nephrectomy,; Simple Nephrectomy; Partial Nephrectomy; Pain,acute; Pain,postoperative
• Other Study ID Numbers: 1801979369

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