Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04364477 |
| Other study ID # |
Other Identifier-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2015 |
| Est. completion date |
February 1, 2016 |
Study information
| Verified date |
April 2020 |
| Source |
Cumhuriyet University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
INTRODUCTION: The aim of this study was to investigate the effects of tranversus abdominis
plane (TAP) block placed postoperatively using ultrasound guidance for patients with
caesarean section, myomectomy and hysterectomy under general anesthesia by eliminating
additional pain caused by surgical incision.
MATERIALS AND METHODS: The study has been planned to investigate the postoperative analgesia
of 50 patients with TAP blocks applied and non-applied between the ages of 18-65, who will
pass abdominal surgery. Study has been conducted in a prospective, randomized and controlled
manner. Patients have been classified as those who have undergone TAP block (group: I) and
those without block (group: II).
Description:
The study was conducted in accordance with the Helsinki Declaration Principles (rev.2013) and
with the approval of the local ethical board. After the written and signed approval of the
patients, it has been planned to investigate the postoperative analgesia and comfort of a
total of 50 patients The study examined the postoperative pain levels after abdominal surgery
with and without TAP block. Subjects were between the ages of 18-65 who will have abdominal
surgery with transverse incision (cesarean section, hysterectomy (benign), myomectomy) and
American Society of Anesthesiologists Physical Status Classification System (ASA) I-II. Our
study is planned to be prospective, randomized and controlled. The individuals to be engaged
were divided into two groups in a randomized form. Randomization was based on a
computer-generated code. In the first group, a total of 25 patients were admitted with 16
cesareans, 6 myomectomies and 3 hysterectomies applied to the TAP block. In the second group,
a total of 25 patients who did not undergo TAP block, no needle intervention, 18 cesareans, 5
myomectomies and 2 hysterectomies were included as the control group. Those with skin
infections, patients with organomegaly (hepatomegaly and splenomegaly), people who did not
give consent to the method, and individuals with allergies to drugs to be used in the
intervention area where Transversus abdominis plane is to be conducted were not included in
the study.
Isolyte® balanced electrolyte solution at a rate of 2 ml/kg/hour was administered to the
individuals whose oral intake was discontinued 8 hours before the surgery. The individuals to
be included in the study were not given any sedative agent on the morning of their surgery.
10 cm visual analog scale (VAS) was explained in detail to all patients before the procedure.
All individuals to be included in the study were followed up with anesthesia monitor (Drager
Infinity Vista XL®), heart rate (CAH), electrocardiography (ECG) (lead II), systolic blood
pressure (SKB) and diastolic blood pressure (DBP) in the preoperative and preoperative
period. After induction of anesthesia with 1 µg/kg fentanyl (Fentanyl, Janssen-Cilag), 0.5
mg/kg rocuronium bromide (Esmeron® vial, Schering-Plough) and 5 mg/kg thiopental sodium
(Pental Sodium®, I.E Ulagay), 4-6% Desflurane (Suprane® Volatile Solution, Pharmacist-Head -
Baxter) and 50% N2O in Oxygen were used to maintain anesthesia following endotracheal
intubation. Differently in general anesthesia management at cesarean operations, 5 mg/kg
thiopental sodium (Pental Sodium®, I.E Ulagay) and 0.5 mg/kg rocuronium bromide (Esmeron®
vial, Schering-Plough) were administered in induction and 4-6% Desflurane (Suprane® Volatile
Solution, Pharmaceutical-headed-Baxter), (50% N2O+50% Oxygen) and 1 µg/kg fentanyl (Fentanyl,
Janssen-Cilag) are added as inhalation anesthesia after umbilical cord clamping in
maintenance. The maintenance dose of rocuronium bromide was 0.15 mg/kg for all cases.
Necessary fluid replacement was performed during the operation. At the end of the operation,
TAP blocks were placed to the 1st group patients.
After the necessary sterilization conditions were established, the linear ultrasound probe
was sterilely coated and placed in the middle of the iliac crest with the end limit of the
ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue,
external oblique muscle, internal oblique muscle, transversus abdominis muscle and peritoneum
were identified. As the tip of the 21Gx100 mm needle (Pajunk®-Uniplex Nanoline cannula with
facet tip) passed through the muscular layers and fascia, a fascial click was felt and the
needle was advanced with ultrasound in a controlled manner. After receiving the second click
sensation (passage of the fascia of the internal oblique muscle), after a 0.5-1 ml test dose,
the location of the needle was fixed and frequently aspirated and applied to the bilateral
neurophysical plan so that 20 ml of 0.25% bupivacaine (Marcaine® 0.5%, Astra Zeneca) was
applied to one side.
The first group of patients were awakened after TAP block treatment and reversal of muscle
relaxant with atropine sulphate and neostigmine; the control group was awakened after
reversal of muscle relaxant with atropine sulphate and neostigmine at the end of the
operation. When VAS>3 in the postoperative period, 1g of paracetamol was administered as an
intravenous infusion over 10 minutes in terms of the first analgesic requirement.
Systolic and diastolic arterial pressures, heart rate of all patients were monitored
immediately before and postoperatively at 30th minute and 1st, 2nd, 4th, 6th, 12th and 24th
hours after block administration. The pain levels of the patients were measured at the 30th
minute, 1st, 2nd, 4th, 6th, 12th and 24th postoperative VAS values. The need for nausea,
vomiting, and initial analgesia was recorded. In this study, none of the patients underwent
any invasive procedures other than routine procedures.
When parametric test counts were fulfilled (Kolmogorov-Simirnov) by uploading the data
obtained from our study to SPSS (ver:22.0) program, significance test of the difference
between the two averages, variance analysis in repeated measurements, Bonferroni test, Mann
Whitney U test, Wilcoxon test, Freidman test and Chi-square test were used when parametric
test assumptions were not fulfilled. When α is taken as 0.05, β: 0.10, 1-β: 0.90, 25
individuals were included in each group and the strength of the test was p= 0.90388.
Our data were reported as arithmetic mean, standard deviation, number of individuals and the
level of error was taken as 0.05.
