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NCT Number: NCT06742177

Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA)

Laparoscopy is a surgical technique used for basic diagnosis and treatment. The advantages of laparoscopic techniques compared to open surgery have been demonstrated by studies. With the developing medicine and technology, minimally invasive approaches have been targeted in interventional procedures. In laparoscopic surgeries, access to the abdomen is provided with the help of a trocar and a temporary pneumoperitoneum is created with gas insufflation. Despite all these developments, even when laparoscopic techniques are used, postoperative pain is the most disturbing issue for patients. Postoperative pain can seriously reduce the quality of life in patients and acute pain can even trigger chronic pain syndromes. Epidural analgesia, paravertebral, erector spinae plane, intercostal nerve, transverse abdominis plane, external oblique, modified thoracoabdominal plane, rectus sheath block are used for anesthesia and analgesia during laparoscopic abdominal surgeries (LAS). In recent years, regional nerve blocks, including erector spinae plane block (ESPB) and modified thoraco-abdominal plane block (M-TAPA), have been applied for the treatment of pain in patients undergoing LAS due to various causes. ESPB was first described by Forero et al. in 2016 and has been frequently used for the treatment of acute pain in the postoperative period following abdominal surgeries. ESPB can be applied at any level from cervical to sacral, covering dermatomes appropriate for the surgical area under USG guidance. Cadaver studies for the ESPB mechanism have shown that local anesthetic spreads ipsilaterally and contralaterally and that it has analgesic efficacy both on the side where it is applied and on the opposite side. This peripheral nerve block, which is usually applied at a single level, can also be applied at bi-level. Studies have also shown that when ESPB is applied at bi-level, analgesic efficacy increases due to local anesthetic spread.

M-TAPA is a new peripheral nerve block technique defined by Tulgar et al. It has high analgesic efficacy in thoraco-abdominal surgery. It has been shown to be advantageous in upper umbilical surgeries by involving more dermatomes compared to the transverse abdominis plane block. Lateral and anterior branches of thoraco-abdominal nerves are blocked with M-TAPA. It provides analgesia in a wide area between T5 and T12 and can also be applied for LAS. In our clinic, Bi-level ESPB or M-TAPA is routinely applied to suitable patients after anesthesia induction, and intraoperative anesthesia is maintained with inhalation and intravenous anesthetic agents. Multimodal analgesia management has been adopted as postoperative analgesia management.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1-Patients over 18 years of age

2.Those with ASA score I-II-III

3.Those with body mass index (BMI) between 18-40

4.Patients who underwent LAS in the operating room with Bi-level ESPB or M-TAPA

Exclusion criteria

  • Those under 18 years of age
  • Those with ASA score IV and above
  • Those with advanced co-morbidities
  • Those with a history of bleeding diathesis
  • Patients with infection in the area where the block will be performed
  • Those with BMI below 18 and above 40
  • Patients who underwent surgery under emergency conditions

8- Patients with advanced liver and kidney failure

Treatment and study plan

Group Bi-level ESPB

Procedure

The block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae muscle and the transverse process of the relevant vertebra is targeted. The block location is confirmed by injecting 2 ml of saline between the transverse process and the muscle. After the block location is confirmed, a total of 40 ml of 0.25% bupivacaine is applied, using 20 ml of 0.25% bupivacaine for a single level.

Group M-TAPA block

Procedure

The procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the edge of the 10th rib to visualize the lower surface of the costal cartilage in the midline. The block location is confirmed by injecting 2 ml of saline onto the transverse abdominis muscle under the 10th costal cartilage. After the block location is confirmed, 20 ml of 0.25% bupivacaine is used. This procedure is repeated for the opposite side and a total of 40 ml of 0.25% bupivacaine is used.

Primary outcomes

  1. Intraoperative opioid consumption.

    Time frame: Intraoperative period

    Intraoperative opioid consumption will be recorded.

Secondary outcomes

  1. Pain Scores

    Time frame: 24 hours after surgery

    Pain will be assessed using a numerical rating scale from 0 (no pain) to 10 (worst pain) at rest and during coughing. Pain assessment will be made at 1, 2, 6, 12, and 24 hours after surgery. The numerical rating scale is 10 (worst) severe, unbearable pain; 0 (best) no pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Savaş Altınsoy, Assoc Prof

CONTACT

[email protected]

00905332257104

Seyyid Furkan Seyyid Furkan, MD

CONTACT

[email protected]

00905301539252

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA) in Laparoscopic Abdominal Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

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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