Clinical trial NCT06116409: Efficacy of Modified Thoracoabdominal Nerves Block Through Perichondrial Approach in Total Laparoscopic Hysterectomies
Official title: Efficacy of Modified Thoracoabdominal Nerves Block Through Perichondrial Approach in Total Laparoscopic Hysterectomies on Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between September and November 2023, 50 patients aged 18-65 with ASA (American Society of Anesthesiologists) physical status classification of I-III, who are scheduled to undergo elective total laparoscopic hysterectomy, will participate in the study.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* electively total laparoscopic hysterectomy operations

  * ASA II-III,
  * between 18-65 years

Exclusion Criteria:

* ASA IV and above • over 65 - under 18 years of age allergy to local anesthetics

Primary outcomes:
measure: Evaluate patients' postoperative pain
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital
state: İ̇stanbul
Study officials:
affiliation: Kartal Dr Lutfi Kırdar City Hospital
name: hülya yılmaz ak
role: PRINCIPAL_INVESTIGATOR
References: