Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06129383 |
| Other study ID # |
2023-16/7 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 7, 2023 |
| Est. completion date |
May 7, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Uludag University |
| Contact |
Özlem Gök |
| Phone |
+905469379652 |
| Email |
ozlmgktp[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the study is a clinical study that will be conducted on women between the ages of 18 and 75
who are scheduled for breast surgery. We aimed to compare the postoperative pain management
effect of adding the pecto intercostal fascial plane block to the serratus anterior plane
block.
Description:
Patients between the ages of 18-75 who are scheduled for breast surgery, who are in American
Society of Anesthesiologists (ASA) class I-III groups, who are not pregnant or suspected of
being pregnant, and who approve the informed consent form will be included in the study.
Patients with known local anesthetic allergy or suspected coagulopathy, injection site
infection, serious neurological or psychiatric disorder, severe cardiovascular disease, liver
failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2) and chronic opioid use
are excluded from the study will be left.
Within the scope of this study, two different research groups were identified for which
clinical research was planned. The significance level of the power analysis was determined as
0.05 and the power level was determined as 0.80. However, for this study, it was decided to
consider the effect size value as 0.4, based on similar studies in the literature. It was
deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to
include n = 30 cases in each group, considering a 20% wastage margin. The cases will be
divided into 2 groups of 30 people using the sealed envelope method. Group I will include
patients who underwent SAP block under general anesthesia (Control group), and Group II will
include patients who underwent SAP and PIFB block under general anesthesia (Experimental
group). Demographic information (weight, height, age, body mass index, comorbidity ASA score)
of all cases will be recorded. After informed consent was obtained in all cases; Standard
monitoring including HR, SS, SpO2 non-invasive blood pressure, and 5-lead electrocardiography
will be performed. Following anesthesia induction with midazolam 0.05 mg\kg intravenous (IV),
propofol 2.5 mg\kg IV, fentanyl 2 mcg\kg IV, lidocaine 1 mg\kg IV and rocuronium 1 mg\kg IV,
which the investigators routinely use in our clinic for general anesthesia. It is planned to
maintain anesthesia with sevoflurane in patients whose airway is provided with a laryngeal
mask, with a minimum alveolar concentration (MAC) of 1. The patient is placed in the lateral
decubitus position and serratus guided by the 38 mm 6 MHz linear probe of the ultrasound
device, which is routinely applied to Group I (Control group) patients in our clinic. SAP
block will be applied to the anterior muscle fascia using 20 ml of 0.25% bupivacaine
solution. For Group II (Experimental group) patients, SAP block will be applied to the
serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution, accompanied by the
38 mm 6 MHz linear probe of the ultrasonography device that is routinely applied in our
clinic. The patient will be placed in the lateral decubitus position. Then, the patient will
be placed in the supine position and 4 strokes will be applied in the parasternal region.
PIFB will be applied using 10 ml of 0.25% bupivacaine solution between the pectoralis major
and external intercostal muscle fasciae at the level of the intercostal space. In the
intraoperative period, paracetamol 1000 mg IV and tenoxicam 20 mg IV will be administered to
all patients as the investigators routinely apply. The patients' hemodynamic data and the
amount of opioid used during the operation will be recorded every 30 minutes during the
intraoperative period.
In the postoperative period, patients' visual pain score (VAS) and VAS score during movement
will be measured at the 1st, 2nd, 4th, 8th, 12th and 24th hours. In addition, the patients'
first additional analgesic time, additional analgesic requirement and consumption amount will
be recorded.
It is planned to give paracetamol 4x500 mg IV as a rescue analgesic in patients with a VAS
score of 4 and above in the postoperative period, and tramadol 1 mg\kg IV as a second rescue
analgesic in patients whose VAS score continues to be 4 and above during their follow-up.
