Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04320212 |
| Other study ID # |
M D-82 -2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
March 22, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Surgical procedures on the spine and spinal cord are common and are performed for a wide
variety of diseases. They range from minimally invasive, single-level decompression to highly
complex, multi-stage extensive reconstruction. Operative procedures for degenerative spine
diseases and herniated discs are most common in those under 60 years of age. While those over
60 years of age most commonly undergo spine surgery for spinal stenosis
Patients undergoing spine surgery experience severe pain in the postoperative period. Recent
studies show that the incidence of acute postoperative pain following spine surgery vary from
30 to 64%. Postoperative pain may also increase morbidity and incidence of complications and
prolong postoperative rehabilitation. In addition, it is a risk factor for development of
chronic pain syndromes
Postoperative pain is usually treated with oral or intravenous opioids in combination with
non-steroidal anti-inflammatory drugs. However, they often results in insufficient pain
control and side effects such as respiratory depression, nausea, and vomiting.
Epidural anaesthesia and analgesia have been shown to be superior to intravenous analgesia.
The former is better with respect to pain quality, incidence of side effects, pulmonary,
cardiac, and gastrointestinal dysfunction. However, it may be associated with hemodynamic
instability. Migration of the epidural catheter with unpredictable absorption of the local
anaesthetics remains a challenge to the anaesthetists. The Erector Spinae block proved to be
efficient in controlling post-operative pain. It is a simple interfascial plane block,
published in 2016. It provides effective analgesia for 24 hours in patients undergoing lumbar
spine surgery.
Therefore, a prospective, randomized study was designed to compare the analgesic and side
effects of the epidural analgesia with the Erector Spinae block in patients undergoing lumbar
spine surgery. To our knowledge, this is the first clinical trial that compares the Erector
Spinae block with the epidural analgesia in a variety of lumbar spine surgeries.
Description:
History will be taken from all patients. Age and then American Society of Anaesthesiologists'
(ASA) score will be recorded.
Preoperatively patients' pain score, laboratory investigations as complete blood picture,
coagulation profile, liver and renal functions will be recorded. General examination will be
carried out with examination of the back to exclude infection at the injection site and
anatomical deformities.
Baseline vital signs will be recorded including non-invasive measurement of systolic, mean,
diastolic arterial pressures, and heart rate and oxygen saturation.
After inserting an intravenous (IV) access, the patient will be pre-medicated with midazolam
in a dose 0.1 mg/kg and metoclopramide in a dose 0.1-0.2 mg/kg.
Upon arrival to the operating room, appropriate monitors (continuous pulse oximetry,
electrocardiography and non-invasive blood pressure) will be placed. Then, general
anaesthesia will be induced. 1.5 μg/kg fentanyl and 2 mg/kg propofol will be given. Tracheal
intubation will be facilitated with 0.5 mg/kg atracurium. Anaesthesia will be maintained
using isoflurane in oxygen and air. Additional doses of 0.1 mg/kg atracurium will be
administrated every 30 minutes. A urinary catheter will be placed for control of diuresis.
the patient will receive either lumber epidural or erector spinae analgesia according to the
group randomization.
The surgical intervention will be then allowed 20 minutes after finishing the block
procedure.
Failed block is defined as increase in heart rate (HR) and mean arterial blood pressure
(MABP)>20% from base line with skin incision. This will be treated by 1ug /kg of fentanyl as
top-up doses and increasing isoflurane concentration in case of inadequate response to
fentanyl.
In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer
infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be
given.
postoperative nausea and vomiting will be managed with 0.1 mg/kg ondansetron
