Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy
Status: | Recruiting |
---|---|
Conditions: | Nephrology |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | May 22, 2018 |
End Date: | December 30, 2020 |
Contact: | Kevin M Backfish-White, MD |
Email: | kmbackfi@iupui.edu |
Phone: | 317-944-4338 |
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.
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.
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.
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.
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
We found this trial at
1
site
550 University Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Phone: 317-944-4338
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