Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04336111 |
| Other study ID # |
retrolaminar block |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2023 |
| Est. completion date |
April 10, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral
curvature and rotation of the vertebrae with functional limitations and cosmetic problems,
idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of
all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity
when the deformity progressively worsens and cannot be positively corrected by brace
treatment. Spinal correction surgery is one of the most invasive surgical procedures and
usually results in moderate to severe levels of postoperative pain. (3) Severe pain may
induce implant complications such as construct dislodgement, broken instrumentation, and
implant loosening which requires additional revision procedures These conditions adversely
affect postoperative outcomes.(4) In the past several years, pain has become an important
indicator for evaluating indicators of outcome and quality of life after surgery. Effective
analgesia after surgery could improve patients' prognosis.(5) The retrolaminar block is a
recently described ultrasound-guided technique in which local anesthetics is injected into
the fascial plane between the posterior surface of the thoracic lamina and the overlying
transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar block is
effective in reducing opioid requirements and improving the pain experience in a wide range
of clinical settings. They are best employed as part of multimodal analgesia with other
systemic analgesics
Description:
-Preoperative: Evaluation of patients will be carried out through proper history taking,
clinical examination and routine laboratory investigation and patients will be trained to use
the Numerical Rating Scale (NRS 0= no pain, 10= intolerable pain) used for evaluation of pain
intensity.
The patient is allowed to fast for 8 hours for solids and 2h for clear fluid. Before the
study, all patients will be interviewed and will be briefed on the wake-up test procedure.
They will be informed that they will be asked to open their eyes, move their fingers (hold
the anesthesiologist's hand), move their toes, and finally, to remember a given color.
-Intraoperative: On arrival to operating roome, a 20 G peripheral IV cannula will be
inserted. Electrocardiogram (ECG), noninvasive mean arterial blood pressure (MAP) and
peripheral oxygen saturation will be attached and baseline data will be monitored and
documented. Sedation will be given intravenously in the form of midazolam 0.02 mg/kg and IV
fliud according to calculation of deficit and maintaince calculation.
After preoxygenation, anesthesia with IV propofol 2 mg/ kg and fentanyl 2 µg/kg will be
administered for analgesia and cisatracurium 0.5 mg/ kg will be given intravenously to
facilitate endotracheal intubation.
Central venous catheter will be inserted and attached for monitoring of CVP. Also, enotropy
will be connected on the patientꞌs forehead and maintained between 40-60.
44 patients will be equally divided to two equal groups (22 patients for each group) Group 1:
will receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10
after induction of anaesthesia in prone position.
Group 2: will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and
T10 after induction of anaesthesia in prone position. The total desired volume used in the
whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml.
The total 40 ml volume will be divided into 10 ml for each injection.
Maintaince of anaesthesia will be 50 : 50 % O2 to air and sevoflurane 2% and cisatracurium
incremental every 30 min at dose of 0.1 mg/kg. I.V analgesia in form of incremental fentanyl
1 ug /kg when entropy increases more than 60 during surgery and 30 min before the wake-up
test.
Wake up test: Before continuation of anesthesia, patients will be given a color to remember.
After finishing the wake-up test, anesthesia will be induced using 3 mg/kg propofol and 0.1
mg/kg cisatracurium, whereas anesthesia will be maintained as described previously.
At the end of surgery, inhalational anesthetic agent will be turned off, residual
neuromuscular block will be reversed with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg then
patients will be extubated and will be transferred to post anesthesia care unit (PACU).
Postoperative multimodal analgesia: will received paracetamol 10 mg/kg every 6 hours and
intravenous diclofenac 1.5 mg/kg every 8 hours regularly.
All observations will be carried out by a single investigator, who is blinded to the study
groups.
-In all groups, the following will be measured: -
1. Demographic data.
2. Time of the first dose of rescue analgesia (morphine at dose of 0.1 mg/kg).
3. Total doses of postoperative morphine consumption.
4. Number of patients received rescue analgesia.
5. Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 =
intolerable pain). If score is >3 will need analgesia in the form of morphine 0.1 mg/kg
will be given till NRS decreases to ≤3. NRS will be assessed and recorded on arrival to
the Recovery Unit, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist,
who is blinded to the study groups.
6. Total doses intraoperative consumption of fentanyl.
7. Wake-up profile: On the surgeons' request for the intraoperative wake-up test,
administration of sevoflurane will be stopped. (the quality of wake-up, return of
spontaneous breathing, ability to open eyes on command, and ability to move hands and
feet) and postoperative amnesia. Patients will be asked repeatedly during the wake-up
test, at least every 15 s, to open their eyes and to move their hands and feet. The time
elapsed from the interruption of anesthesia to the start of spontaneous breathing (T1),
from the return of spontaneous breathing to eye opening on command (T2), and from eye
opening to movement of hands and feet (T3) will be recorded in seconds using a
stopwatch. The quality of the wake-up test will be evaluated on a three-point rank scale
(7).
8. First time of postoperative mobilization.
