Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06116409 |
| Other study ID # |
DrLutfiKirdarANESTHESIA |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
TAPA is a new analgesic block technique that involves the injection of local anesthetics into
the thoracoabdominal nerves using a perichondrial approach. Application to the undersurface
of the rib cartilage is considered as Modified TAPA (M-TAPA). These techniques are commonly
applied for postoperative analgesia in surgeries and are effective and safe when performed
under ultrasound guidance.
Description:
Between September 2023 and October 2023, a study will be conducted involving 50 elective
total laparoscopic hysterectomy patients aged 18-65 with ASA (American Society of
Anesthesiologists) physical status classification of 1-3. Patients with ASA status 4 or
higher, aged 65 and above, under 18 years of age, those who have previously undergone
laparotomy, or those with a known local anesthesia allergy will not be included in the study.
Patients who require intubation and are admitted to the intensive care unit, or those who
experience mortality, will be excluded from the study.
One day before surgery, all patients will undergo a preoperative assessment and provide
written informed consent to participate in the study. Patients will be randomly assigned to
groups using a computer-generated random table. In Group 1, patients will receive a modified
thoracoabdominal nerve block (M-TAPA) with a perichondrial approach using 40 ml of 0.25%
bupivacaine guided by ultrasound (US). In Group 2 (the control group), routine multimodal
analgesia (tramadol 1 mg/kg, paracetamol 15 mg/kg) will be administered. The needle-like
spread of bupivacaine or saline beneath the undersurface of the rib cartilage, observed under
US, will indicate the success of the procedure. These procedures will be performed
postoperatively. At the end of the surgery, both groups will receive 1 mg/kg tramadol IV and
15 mg/kg paracetamol IV for analgesia.
Demographic data, medical history, ASA classification, and the presence of coronary artery
disease (CAD) and overactive bladder (OAB) before and after M-TAPA, anesthesia time, surgical
duration, time to tracheal extubation (time after skin closure), total remifentanil and
muscle relaxant doses, total fluid administered, urine volume, and the total volume of
allogeneic erythrocytes and plasma infused during the surgery will be recorded. Additionally,
postoperative hypotension development (systolic blood pressure dropped more than 30% from
baseline or SBP < 80 mmHg before anesthesia), nausea and vomiting, hypoxemia (SpO2 < 90% or
PaO2 < 60 mmHg), hypercapnia (PaCO2 > 45 mmHg), and agitation during the waking period will
be recorded.
In the ward, 2*1 non-steroidal anti-inflammatory drugs (NSAIDs) will be administered for
analgesia. Numerical Rating Scale (NRS) will be assessed postoperatively at 2, 6, 12, and 24
hours, and tramadol consumption will be recorded. A numerical rating scale (NRS) ranging from
0 (no pain) to 10 (worst imaginable pain) will be used for pain assessment. If NRS is greater
than 4, rescue analgesia with tramadol will be administered. After surgery, all patients will
be transferred to the post-anesthesia care unit (PACU).
