Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05312957 |
| Other study ID # |
AbantIBU mb6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2020 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Abant Izzet Baysal University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of
pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia
is not provided in such surgeries, pulmonary and cardiovascular complications may develop.
This study aimed to provide effective analgesia and reduce postoperative opioid consumption
by applying preemptive erector spinae plane (ESP) block.
Methods: A total of 50 patients who underwent CABG surgery were included in this prospective
randomized controlled study. Patients were randomly divided into two groups: the ESP group
and the control group. The intervention to the ESP group was applied bilaterally at the T5
level before the surgery. The primary outcome was postoperative opioid consumption; the other
outcomes included visual analog scale scores, intraoperative opioid consumption, and duration
of hospital stay.
Description:
Study Design and Patient: This prospective randomized study was conducted with the approval
of the local ethics committee of the Bolu Abant Izzet Baysal University in Turkey (Approval
date 03/11/2020; Decision no. 2020/243). All patients who agreed to participate in the study
were informed about the purpose of the study and the anesthesia method to be used, and their
written consent was obtained. Sixty-five patients, aged 50-75 years, at the risk of American
Society of Anesthesiologists (ASA) III, who was planned off-pump CABG surgery were invited to
the study between November 2020 and April 2021. In the preoperative evaluation, patients with
hypersensitivity to the drugs to be used or the substances in their composition, having
moderate or severe left ventricular dysfunction, bleeding disorders, liver and kidney
failure, chronic obstructive pulmonary disease, patients who do not have sufficient
intellectual capacity to use the PCA device, and who refused to participate in the study were
excluded from the study. In the intraoperative period, patients who needed a cardiopulmonary
bypass pump and those who needed an aortic balloon pump support were excluded from the study.
In the postoperative period, patients for whom the extubation duration was longer than four
hours and those who required re-exploration were excluded from the study The groups were
randomized; It was divided into Group E (ESP Group) and Group C (Control Group). The
Ramdom.org program (https://www.random.org/lists/?mode=advanced) was used for the
randomization of the groups. Demographic data (gender, age, weight, height, body mass index
(BMI)) of all patients were recorded. The patients were taken to the operating room without
premedication. and electrocardiography (ECG), heart rate (HR) Sist, and peripheral oxygen
saturation (SpO2) values were monitored and two peripheral vascular accesses were established
with an 18-gauge intravenous (IV) cannula. To provide continuous arterial blood pressure
monitoring, the radial artery was cannulated by applying topical anesthesia after the Allen
test.
Interventions In Group E patients, a prone position was given before general anesthesia
induction. Compliance with the rules of asepsis-antisepsis was achieved. A Sonosite-180 Plus
model USG (L38/10-5 MHz Transducer, SonoSite Inc., Bothell, WA 98021 USA) was used for the
intervention. An adjusted linear probe was used, which was set to a depth of 2-5 cm and a
frequency of 10-15 MHz. The probe was placed craniocaudally in the parasagittal plane
approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected
using a planal approach. Before the procedure, the skin, subcutaneous tissue, trapezius,
rhomboid, and erector spinae muscles were identified, and local anesthesia was administered
using 2% lidocaine (Aritmal 2% ampoule, Osel Medicine Istanbul, Turkey). When the block
needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of
the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the
vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25%
bupivacaine (Buvasin 0.5% Vem Medicine Istanbul, Turkey) was administered to this area, and
an ESP block was applied (Figure 1). The same procedure was performed on the opposite side,
and a bilateral ESP block was applied. The block was considered successful when cold loss
developed. No preoperative procedure was applied to the Group C patients.
Anesthetic Management For the induction of general anesthesia, 2 µg/kg fentanyl (Talinat 50
mcg/ml VEM İlaç San. ve Tic. A.Ş. İstanbul, Turkey), 2 mg/kg propofol (Propofol Lipuro 1%
10mg/ml ampoule, B. Braun, Melsungen, Germany), and 0.6 mg/kg rocuronium (Esmeron 50mg/5ml
Merck Sharp Dohme İlaçları Ltd. Şti. Levent/Istanbul) were given intravenously and the
patient was intubated after adequate muscle relaxation was achieved. Then, central venous
access was achieved. For anesthesia maintenance, 2% sevoflurane (Sevorane® Liquid 100%,
AbbVie, Queenborough Kent, England) was used in 50% air and 50% oxygen. Fentanyl (0.5-2
mcg/kg) was administered 1-2 minutes before the thorax incision. An additional 1-2 mcg/kg of
intravenous (IV) fentanyl was administered to patients with a 20% increase in blood pressure
or heart rate. After induction, 1 mcg/kg fentanyl, and 0.25 mg/kg rocuronium were
administered at half-hour intervals in both groups. Before cross-clamping the ascending
aorta, the systolic pressure had aimed to be below 100 mmHg. To maintain a systolic pressure
below 100 mmHg, patients were administered 1-2 mcg/kg fentanyl when necessary. Intraoperative
fentanyl consumption was recorded. During anesthesia, intermittent arterial blood gas
monitoring was performed on all patients. The anesthesia and surgery durations of the
patients were recorded, and they were taken to the intensive care unit (ICU) as intubated
after the operation. The patients were extubated within 4 hours postoperatively.
Patient-controlled analgesia devices were applied to all patients after extubation. Tramadol
HCl (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul/Turkey) was adjusted as IV bolus 20
mg doses of tramadol HCl every time a button was pressed, at a concentration of 5mg/ml. The
device was adjusted to allow a maximum dose of 400 mg in 24 hours, with a lock-in time of 20
minutes; total tramadol consumption was recorded. After extubation, VAS values were recorded
at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th, 36th, and 48th postoperative hours. During the
0-1, 1-12, 12-24, 24-36, and 36-48 time zones, heart rate, systolic blood pressure, mean
blood pressure, diastolic blood pressure, and peripheral oxygen saturation were monitored and
recorded. Nausea, vomiting, pruritus, desaturation, urinary retention, and other side effects
were followed up and recorded in the patient follow-up after extubation. Postoperative nausea
and vomiting were treated with 4mg of ondansetron (IV) (Ondaren 4mg/2ml Vem İlaç A.Ş
Istanbul, Turkey), and rash and itching with 45.5 mg of pheniramine (IV) (Avil amp 45.5mg/2ml
Sandoz İlaç A.Ş. Istanbul/Turkey). When the VAS was above four, IV 0.05 mg/kg morphine
(Morphine HCL® 0.01 g/ml amp Galen İlaç A.Ş./Turkey) was administered as rescue analgesia.
The extubation and ICU discharge times of the patients in both groups were recorded
