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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| Group #1 | Active comparator | Transverses Abdominis Plane (TAP) block Receives: Procedure: Transverses Abdominis Plane (TAP) block |
| Group #2 | Active comparator | Quadratus Lumborum (QL) block Receives: Procedure: Quadratus Lumborum (QL) block |
| Group #3 | Active comparator | Surgeon 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.
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
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)
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.
- First posted10 Jul 2018
- Study start22 May 2018
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Michael Backfish-White, Indiana University
- Investigators
- Kevin M Backfish-White, MD, Principal investigator, Indiana University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03581539
- Acronym / sponsor ID
- 1801979369
- Conditions
- Nephrectomy
- Keywords
- Laparoscopic Nephrectomy,, Simple Nephrectomy, Partial Nephrectomy, Pain,acute, Pain,postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group #1 | Active comparator | Procedure: Transverses Abdominis Plane (TAP) blockTransverses Abdominis Plane (TAP) block |
| Group #2 | Active comparator | Procedure: Quadratus Lumborum (QL) blockQuadratus Lumborum (QL) block |
| Group #3 | Active comparator | Procedure: Surgeon Infiltration using ExparelSurgeon Infiltration using Exparel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic nephrectomy including partial, simple and radical nephrectomy
- ASA class 1, 2, 3 or 4
- Age 18 or older, male or female
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverses Abdominis Plane (TAP) blockTAP 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. | Procedure or surgery | Group #1 |
| Quadratus Lumborum (QL) blockQL 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. | Procedure or surgery | Group #2 |
| Surgeon Infiltration using ExparelSI 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. | Procedure or surgery | Group #3 |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin M Backfish-White, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
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.