Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04371341 |
| Other study ID # |
_MD-248-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2020 |
| Est. completion date |
July 3, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Since its first description by Forero et al. there have been many articles and case reports
including an increasingly number of indications for the ESP block: chronic and acute pain
treatment, rib fractures management in the emergency setting, treatment of abdominal surgical
pain, hip arthroplasty , analgesic management in breast surgery,or in spinal surgery.Although
ESP block successfully reduced postoperative opioid consumption in clinical reports, no
studies thus have investigated the optimum volume of bupivacaine for ESP block as regard a
review of the medical literature on December 27th, 2017 that searched terms in 14 articles
clearly stated the volume of the bolus and the spread of the anesthetic after an injection of
LA, the volume needed to cover one dermatome widely varies from 2.5 mL to 6.6 mL, with a
median value of 3.4 mL. Furthermore, the maximum number of dermatomes reached by a single
bolus in ESP was of 9 dermatomes after a 30 mL bolus.
Thus, in this study, the investigators evaluate the effect of ESP block which will be
performed by using three different volumes (2.5, 3.4 ,6.6 ml/segment) of bupivacaine with the
same concentration ,technique ,site of injection and operation.
Description:
INTRODUCTION In recent years a number of important fascial plane blocks have been described
blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdome].The
advantage common to all of these blocks is that they are technically easier to perform with
lower risk for serious complications.Since its first description by Forero et al. there have
been many articles and case reports including an increasingly number of indications for the
ESP block: chronic and acute pain treatment , rib fractures management in the emergency
setting , treatment of abdominal surgical pain , hip arthroplasty , analgesic management in
breast surgery ,or in spinal surgery.The ESP block targets the erector spinae plane, which
lies in the chest wall between the anterior surface of the cephalo caudal oriented erector
spinae muscles and the posterior surface of the spinal transverse processes. LA is deposited
in the fascial plane deep to the erector spinae muscle and superficial to the tips of the
transverse processes, from where it diffuses to the dorsal and ventral rami of spinal nerves,
achieving an extensive multi-dermatomal sensory block of the posterior, lateral, and anterior
thoracic wall .Chin et al reported that an injection of 20 ml into the ESP produces clinical
and radiographic evidence of spread that extends at least three vertebral levels cranially
and four levels caudally from the site of injection.A study with magnetic resonance imaging
demonstrated and confirmed that its mechanism of action is likely linked to the
transforaminal and epidural spread, which may be a potential advantage because the ESP block
provides abdominal visceral analgesia unlike the others .beside its ability to spread to
paravertebral and intervertebral spaces and ability to block the sympathetic nerve fibers.
the ESP block is considered as a peri-paravertebral regional anesthesia technique.LAs, is
injectted with volumes ranging from 20 mL to 40 mL, and concentrations ranging from
0.25%-0.5%.even though a higher LA concentration might allow for better diffusion into the
paravertebral space .
Open surgery remains common for patients requiring radical or partial nephrectomy and is
associated with a high incidence of intense immediate postoperative pain and chronic pain in
the months following surgery. ESP block was for open partial nephrectomy with excellent
results both in the intraoperative and postoperative period, with a large reduction in the
use of opioids.
Although ESP block successfully reduced postoperative opioid consumption in clinical reports,
no studies thus have investigated the optimum volume of bupivacaine for ESP block as regard a
review of the medical literature on December 27th, 2017 that searched terms in 14 articles
clearly stated the volume of the bolus and the spread of the anesthetic after an injection of
LA, the volume needed to cover one dermatome widely varies from 2.5 mL to 6.6 mL, with a
median value of 3.4 mL. Furthermore, the maximum number of dermatomes reached by a single
bolus in ESP was of 9 dermatomes after a 30 mL bolus.
Thus, in this study, the investigators evaluate the effect of ESP block which will be
performed by using three different volumes (2.5, 3.4 ,6.6 ml/segment) of bupivacaine with the
same concentration ,technique ,site of injection and operation.
Methodology:
Eighty Patients, aging from 18-50 years with ASA physical status I and II, undergoing open
simple nephrectomy will be included and randomly distributed into 4 groups with 20 patients
for each group where group C will not receive erector spinae block and so will be the control
group while groups which will receive erector spinae block will be E1,E2,E3 and will receive
0.25% bupivacaine with volumes of 2.5,3.4,6.6 ml/segment respectively.
The day before surgery, all patients will be instructed to fast for 6-8 hours. On the day of
the operation,the patient will arrive to the preparation room 1 hour before operation,to
allow time for the block procedure and a minimum of 45 minutes after the block to pass, an 18
G cannula insertion, a start of IV fluid drip, and premedication with 0.02-0.03 mg/kg
intravenous midazolam will be done. All basic monitoring will be applied (ECG/HR/SpO2/NIBP),
and baseline values for HR, SPO2 ,SBP,DBP and MAP will be documented then every 5 minutes
till the patient reaches the operating room.
A mark will be applied on the required level (T8), the midline (spinous processes) and the
injection points 3 cm from midline.While the patient is in a sitting position with support
from a member of staff, Preparation of the field with iodine will be made. Using ultrasound
guidance with a 6-10 MHz linear probe anatomical landmarks will be identified including the
transverse process at T8 level and the three layers of muscles from posterior to anterior:
trapezius-rhomboid-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal
needle will be inserted under ultrasound guidance in plane, aiming towards the transverse
process. After a Gentle contact with the transverse process, the volume of 0.25% bupivacaine
will be injected according to each group 2.5, 3.4 ,6.6 ml/segment in increments with careful
repetitive aspiration to avoid intravascular injection.
Spread of the local anesthetic will be monitored by U/S anterior to erector spinae muscles
(dividing erector spinae muscles from transverse process with caudal and cephalic spread)
then the end point of local anesthetic will be marked and the corresponding covered level
will be assessed caudal and cephalic from T8.onset of the block will be tested by pin brick
test every 10 minutes after performing the block maximum 30 minutes otherwise it will be
considered failed block and documented for each group while dermatomal spread will be
assessed by pin brick test 30 minutes after onset of the block and will be documented.
Then the patient will be transferred to the OR. All basic monitoring will be applied
(ECG/HR/SpO2/NIBP) while monitoring of end-tidal CO2, neuromuscular block and depth of
anesthesia using Bispectral index (BIS) monitor will be initiated after induction of
anesthesia and values will be recorded for HR, SPO2 ,SBP,DBP ,MAP and ETCO2 every 5 minutes
till the end of the surgery then for 30 minutes from time of reaching PACU.
General anesthesia will be inducted with 2 mg/kg propofol, 1μg/kg fentanyl and 0.5 mg/kg
atracurium to facilitate endotracheal intubation. After intubation the lungs will be
mechanically ventilated to maintain the ETCO2 35-40 mmHg. Then Patient positioned in the
lateral position. Anesthesia will be maintained with isoflurane keeping the ET concentration
of isoflurane 1-2% to maintain the BIS value 40-60. Atracurium besylate top-up doses 0.1mg/kg
will be given based on the response to train of four ulnar nerve stimulation. Additional
fentanyl dose of 0.5 µg/kg IV for maximum of 2 µg/kg will be given if HR and or BP increased
more than 20% from baseline in response to surgical stimulation and the total dose of
fentanyl will be recorded.
The patient's pain will be monitored and documented using the Numerical Rating Score (NRS)
for pain at times 0,30 minutes, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours. The "zero" point of
time will be the moment the patient recovered from general anesthesia. Time to first
analgesic requirement will be recorded. Rescue medication for pain will be given on demand
including 1 g paracetamol IV when NRS >/= 2 but < 4 and if NRS is 4 or more a 5 mg morphine
IV with maximum dose of 10 mg every 6 hours and the total consumption of these medications
will be recorded.
