Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04090099 |
| Other study ID # |
2019/14-08 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 17, 2019 |
| Est. completion date |
May 15, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Kahramanmaras Sutcu Imam University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Inadequate pain relief after cardiac surgery increases morbidity and results in a high
incidence of persistent poststernotomy pain syndrome. The use of special opioid-based
analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention,
respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such
as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and
pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and
simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous
process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in
both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal
nerves, including the sympathetic chain. This block may provide adequate analgesia for median
sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median
sternotomy incision and mediastinal tube regions are the major source of pain in patients
undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves
give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is
effective in providing early postoperative analgesia and reducing opioid requirements and
therefore has positive effects on healing. This simple and fast technique can be used even
for anticoagulated patients.
Description:
99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector
Spina, n = 31), Group PS (Parasternal Intercostal Block n = 31) will be randomized.
Randomization was achieved by randomly assigning patients to computer-generated random
numbers. It will be explained that patients can receive both intravenous analgesia treatment
and both blocks that are thought to be done. Patients will be told to express the degree of
postoperative pain in the preoperative preparation room using a numerical scoring scale (NRS)
between 0 and 10 (no pain at 0, no pain at 10). The vascular access will be opened in the
pre-operative preparation room and 2 mg demizolam will be made. All preoperative cardiac
drugs, except antiplatelet and anticoagulants, will be continued until the morning of
surgery.
Demographic structures, cardiopulmonary bypass time, aortic cross clamp time, surgical time,
ejection / fraction values will be recorded.
Weight and height of patients will be recorded (BMI). Preoperative, blood group and typing,
full hemogram, liver function tests, renal function tests, chest radiography,
electrocardiography, 2D transthoracic echocardiography and coronary angiography will be done
as routine investigations.
Platelet count, bleeding time, clotting time, prothrombin time, activated partial
thromboplastin time will be checked in all patients.
Constructional blocks:
1. ESP (Erector Spina Plane) Block Group
2. 2. Parasternal Block Group
3. Control Group The control group will not receive any Erector Spina block and
Paravertebral Block. Only PCA (Patient Control Analgesia) and intravenous analgesic
(Morphine) drug will be used.
The same surgical and anesthesia team will manage the patients. 6 channel ECG and
non-invasive arterial pressure monitoring will be performed after the patients are admitted
to the operation room. A peripheral intravenous line with a 16-gauge needle and a right
radial artery with a 20-gauge needle will be performed. Blood will be taken for preoperative
blood gas. Midazolam 0.01 (mg / kg), fentanyl (5-8 μg / kg) and rocuronium (0.6 mg / kg) will
be used for induction of anesthesia. After anesthesia, central venous catheter and urinary
catheter will be inserted. During general anesthesia Sevoflurane will be used in the
air-oxygen mixture with a concentration of 50% oxygen. Normocapnic variation will be provided
(PCO2 = 35-45). A rocuronium 0.6 mg / kg will be used every 30 minutes. All patients will
undergo median sternotomy. Heparin 300-500 Units / kg to be administered. Activeted clotting
time (ACT) will be kept> 400 throughout the procedure. Esophageal temperature will be
monitored. The mean arterial pressure throughout the operation will be maintained above 60 mm
Hg. Peroperative blood sample will be taken from the radial artery 3-5 minutes after the
cross-clamp is removed. Heparin will be neutralized with protamine 1: 1.3. After the
operation, patients will be transferred to the intensive care unit.
In the intensive care unit, patients will be extubated when the respiratory effort occurs,
when the patient is awake, blood gas values are within normal range, body temperature is
normal and hemodynamically stable. Morphine consumption by PCA and NRS scores will be
monitored and recorded at 1, 3, 6, 12 and 24 hours after extübation. MAP (Mean arterial
pressure), PH, PO2 (Blood gas) follow-ups will be recorded in the first blood gas, extubation
and postoperative 1,2, 4,6,12, 24 hours.Paracetamol 1 g and Tramadol 1mg/kg intravenously
will be administered to the patient if NRS> 3 when the patient is extubated.
If the patient's consciousness and hemodynamic status do not allow pain assessment, the
patient will be excluded from the study. After the surgery, the investigator who evaluates
NRS scores in the ICU will not know which group the patient is.
Oral feeding at postoperative hour, intensive care unit stay day, Side effects Nausea,
Vomiting, Itching to be followed
