Efficacy of Modified Thoracoabdominal Nerves Block Through Perichondrial Approach in Total Laparoscopic Hysterectomies

Efficacy of Modified Thoracoabdominal Nerves Block Through Perichondrial Approach in Total Laparoscopic Hysterectomies on Postoperative Pain

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacain

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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey
      • University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
M-TAPA GROUP; 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).	Drug: Bupivacain; Bupivacaine was used for postoperative analgesia block.
CONTROL GROUP; Patients in Group 2 (the control group) will receive routine multimodal analgesia, which includes tramadol at a dose of 1 mg/kg and paracetamol at a dose of 15 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate patients' postoperative pain	The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of modified thoracoabdominal nerve block (M-TAPA) in total laparoscopic hysterectomy. Numerical rating scale (NRS) will be used for postoperative analgesic effectiveness. 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.	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: hülya yılmaz ak, Kartal Dr Lutfi Kırdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): November 24, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: DrLutfiKirdarANESTHESİA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No