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Enrolling by Invitation

NCT Number: NCT06601413

Modified Thoracoabdominal Nerve Block(M-TAPA) in Total Laparoscopic Hysterectomies

The aim of the study is comparing the postoperative effects of ultrasound-guided Modified Perichondrial Approach to Thoracoabdominal Nerves (M-TAPA) block for postoperative pain control after total laparoscopic hysterectomy.

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Key information

Conditions

Pain,Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University

Ankara, Turkey (Türkiye)

About this study

Pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy.

Multimodal analgesia methods are used in postoperative pain management. Nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today.

Local Anesthetic Infiltration at the Trocar Site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries.

Modified TAPA block applied with ultrasound guidance; It is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. It is used in total laparoscopic hysterectomies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 18-65
  • Elective cases
  • ASA I-III functional status
  • Body mass index (BMI)<35
  • Total laparoscopic hysterectomy planned with general anesthesia
  • No contraindications for M-TAPA block to be applied
  • Cases that give written and verbal consent for participation in the study will be included.

Exclusion criteria

  • Conversion to open surgery
  • Development of perioperative complications (due to surgery and/or anesthesia)
  • Coagulation disorder
  • Infection at the injection site
  • Allergy to local anesthesia
  • Those who used any painkillers in the preoperative 24 hours
  • Those who did not agree to participate in the study

Treatment and study plan

m-tapa block

Other

M-TAPA block will administer ultrasound guided (Sonosite, Inc., Bothell, WA, USA) bilaterally by same anesthesiologist (E.E.) who had more than 10 years experience of regional anesthesia, before weaking from general anesthesia after the surgical procedure. A high-frequency (6-13 MHz) linear probe (HFL38) will be used to identify the transversus abdominis, internal oblique, and external oblique muscles on the costochondral angle in the sagittal plane at the 10th costal margin. In the midclavicular line, between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue, at the level of the 10th rib, 20 mL of 0.25 percent bupivacaine will be injected (arcus costarum). The same procedure will be followed on the other side.

Trocar site local anesthetic infiltration

Other

At the end of surgery, infiltration analgesia will be applied to all trocar entry sites (4 port entries) by the surgeon with 10 ml of 0.25% bupivacaine (40 mL in total) without waking the patient.

Primary outcomes

  1. Postoperative total tramadol consumption for first 24 hours

    Time frame: Postoperative 24 hours

    The intravenous PCA pump will be programmed to deliver a bolus of 20 mg tramadol with a lockout interval of 30 min and no baseline infusion (tramadol 500 mg in 100 mL SF

Secondary outcomes

  1. Postoperative pain scores

    Time frame: at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours

    Pain will be assessed with visual analog score (VAS) in 2 different ways, at rest and with movement (VAS: 0, no pain; 10, worst pain imaginable). VAS scores will be recorded at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Versus Incisional Local Anesthetic Administration for Total Laparoscopic Hysterectomy : a Prospective, Randomized Clinical Study

Important dates

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