Efficacy Of M-TAPA and TAP Block Following Laparoscopic Cholecystectomy

Last updated: April 20, 2024
Sponsor: Mursel Ekinci
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Liver Disorders

Gall Bladder Disorders

Treatment

Transversus Abdominal Plane block

Modified Perichondral Approach Thoracoabdominal Nerve block

Clinical Study ID

NCT06198335
Bursa City Hospital 5
  • Ages 18-65
  • All Genders

Study Summary

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones.

The analgesic effectiveness of TAP block has been demonstrated after laparoscopic cholecystectomy operations. m-TAPA block has been described as an alternative analgesic technique in abdominal surgeries.

The aim of this study is to compare these two analgesic methods in terms of effectiveness for postoperative analgesia management after laparoscopic cholecystectomy operations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Elective laparoscopic cholecystectomy

Exclusion

Exclusion Criteria:

  • Bleeding diathesis
  • Anticoagulant treatment
  • Local anesthetics and opioid allergy
  • Infection at the site of block
  • Patients who do not accept the procedure

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Transversus Abdominal Plane block
Phase:
Study Start date:
January 20, 2024
Estimated Completion Date:
May 10, 2024

Study Description

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones.

Several factors play a role in pain after laparoscopic cholecystectomy. This pain is complex and generally considered to be visceral. These factors are include phrenic nerve irritation caused by CO2 insufflation, abdominal distension, port incisions, the effect of gallbladder removal and individual factors.

Regional analgesia has been widely accepted by both patients and treating physicians and has become an important part of multimodal analgesia techniques. Transversus abdominis plane (TAP) block has been shown to reduce postoperative pain like hysterectomy, cholecystectomy, cesarean section and colorectal surgery.

Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) is performed by applying local anesthetic only to the underside of the perichondral surface. It provides effective analgesia in the anterior and lateral thoracoabdominal area.

M-TAPA is a good alternative for analgesia of the upper dermatome levels and lateral abdominal region and may be an opioid-sparing strategy that provides better quality recovery in patients undergoing laporoscopic surgery. M-TAPA provides analgesia at the T5-T11 level in the abdomen. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen with US guidance. Cephalo caudal spread of local anesthetic solution produces analgesia in several dermatomes. There are studies investigating the efficacy of M-TAPA for postoperative pain management in bariatric surgery in the literature.

Global recovery score (QoR) 15 is a sensitive, reliable and easy method to measure postoperative recovery quality. This scale, which has become a promising tool for assessing the quality of the recovery period, questions various aspects of recovery in 5 different areas: pain, physical comfort, physical independence, psychological support and emotional state. It may be an important scale to evaluate the outcome of changes in healthcare for quality assurance purposes in perioperative clinical studies. For these reasons, the "Standardized Endpoints in Perioperative Medicine" initiative and the European Society of Anesthesia have recommended the use of the QoR-15 scale in clinical studies investigating patient comfort and pain levels after surgery.

The aim of this study was to compare the efficacy of US-guided M-TAPA block and TAP for postoperative analgesia management after cholecystectomy. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.

Connect with a study center

  • Mürsel Ekinci

    Bursa,
    Turkey

    Active - Recruiting

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