Analgesic Effect of Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    68
  • sponsor
    Karaman Training and Research Hospital
Updated on 2 September 2021

Summary

This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.

Description

Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.

Details
Condition LAPAROSCOPIC CHOLECYSTECTOMY
Treatment M-TAPA block, Standard perioperative and postoperative multimodal analgesia
Clinical Study IdentifierNCT05017090
SponsorKaraman Training and Research Hospital
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

Exclusion Criteria

presence of coagulation disorder
refuse to participate
infection at the injection site of the block
known allergy to local anesthetics
advanced hepatic or renal failure
can not communicate in Turkish
history of abdominal surgery or trauma
conversion of laparoscopic to open surgery
consumption of any pain killers within the 24 h before the operation
chronic opioid consumption
pregnancy
alcohol or drug abuse
body mass index (BMI) 35 kg m-2
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