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Enrolling by invitation NCT06601413

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

No phase Interventional Pain,Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: M-TAPA Block, Trocar site local anesthetic infiltration.
Who it may be relevant to
Registry conditions: Pain,Postoperative. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other M-TAPA Block
    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 midclavicula
  • Other Trocar site local anesthetic infiltration
    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 outcome measures

  • Postoperative total tramadol consumption for first 24 hours [Time frame: Postoperative 24 hours]
Secondary outcome measures (1)
  • Postoperative pain scores [Time frame: at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Health Sciences University — Ankara

Identifiers

NCT: NCT06601413 · 2023-KAEK-159

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗