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Recruiting NCT07483190

Effectiveness of Thoracoabdominal Nerve Block (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy

No phase Interventional Postoperative Pain Hysterectomy Plane Blocks

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: Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA).
Who it may be relevant to
Registry conditions: Postoperative Pain, Hysterectomy, Plane Blocks. Basic parameters: 18 years — 70 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

Effectiveness of Modified-Thoracoabdominal Nerve Block With Perichondrial Approach (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy Surgery: A Prospective, Randomized, Double-Blind, Controlled Study

Overview

This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery. Participants will be randomly assigned to one of two groups: The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins. The Control Group: Patients will receive standard postoperative pain management without the nerve block. The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting

Interventions

  • Procedure Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA)
    Under ultrasound guidance, a 22-gauge peripheral block needle is inserted at the costochondral angle (9th-10th ribs). After confirming the position, 20 ml of 0.25% bupivacaine is injected bilaterally into the lower part of the chondrium.

Primary outcome measures

  • Morphine consumption [Time frame: First 24 hours postoperatively]
Secondary outcome measures (3)
  • Postoperative Pain Scores (NRS) [Time frame: Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively]
  • Rescue analgesic drug consumption [Time frame: Within the first 24 hours postoperatively]
  • Incidence of postoperative nausea and vomiting [Time frame: Within the first 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Aged between 18 and 70 years
  • ASA (American Society of Anesthesiologists) physical status I, II, or III
  • Scheduled for elective laparoscopic hysterectomy
  • Voluntary participation with signed informed consent

Exclusion criteria

  • Hepatic or renal disease.
  • Coagulation disorders.
  • Uncontrolled cardiovascular or respiratory diseases.
  • Psychiatric disorders.
  • History of allergy to local anesthetics.
  • History of alcoholism, drug or substance abuse.
  • Body Mass Index (BMI) greater than 35 kg/m2
  • Refusal of the regional block procedure

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
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Istinye University Liv Hospital Bahcesehir — Istanbul

Identifiers

NCT: NCT07483190 · anestezi tapa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗