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NephrectomyNCT03581539

Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy

A study testing Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block and Surgeon Infiltration using Exparel in people with Nephrectomy, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nephrectomy
What is being tested?
Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block and Surgeon Infiltration using Exparel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
22 May 2018to 17 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Nephrectomy
Being tested
Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block, Surgeon Infiltration using Exparel
Keywords
Laparoscopic Nephrectomy,, Simple Nephrectomy, Partial Nephrectomy, Pain,acute, Pain,postoperative
Medical subject headings
Acute Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transverses Abdominis Plane (TAP) blockProcedure or surgery

    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.

  • Quadratus Lumborum (QL) blockProcedure or surgery

    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.

  • Surgeon Infiltration using ExparelProcedure or surgery

    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.

Study groups in NCT03581539
Study groupRoleWhat they receive
Group #1Active comparatorTransverses Abdominis Plane (TAP) block
Receives: Procedure: Transverses Abdominis Plane (TAP) block
Group #2Active comparatorQuadratus Lumborum (QL) block
Receives: Procedure: Quadratus Lumborum (QL) block
Group #3Active comparatorSurgeon Infiltration using Exparel
Receives: Procedure: Surgeon Infiltration using Exparel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pain scores will be measured 24 hours after surgery

  2. 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

    Measured: Pain scores will be measured 48 hours after surgery

Secondary outcomes (1)
  1. 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

    Measured: Opioid consumption will be measured at 1 hour post op, 24, 48, and 72 hours post op. The total amount will be recorded

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2018
  2. Study start22 May 2018
  3. Primary completion17 Nov 2020
  4. Study completion17 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03581539
Sponsor's protocol ID
1801979369
Status last verified
Jun 2023
First submitted
13 Jun 2018
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transverses Abdominis Plane (TAP) block, Quadratus Lumborum (QL) block and Surgeon Infiltration using Exparel in people with Nephrectomy, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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