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OpenTrials
Completed

NCT Number: NCT06116409

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

Drug

Bupivacaine was used for postoperative analgesia block.

Primary outcomes

  1. Evaluate patients' postoperative pain

    Time frame: postoperative 24 hours

    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.NRS assessed at 2, 6, 12, and 24 hours postoperatively.

Secondary outcomes

  1. Number of Participants Requiring Rescue Tramadol Within 24 Hours Postoperatively

    Time frame: Up to 24 hours postoperatively

    Rescue tramadol (50 mg IV) will be administered when NRS ≥ 4. This outcome records whether a participant required rescue tramadol during the first 24 postoperative hours.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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