M-Tapa Block for Laparoscopic Cholesistectomy

Study Overview
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Brief Summary
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Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

Detailed Description
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Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. In this study, the investigators aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy surgery.Primary aim is to compare the postoperative pain scores (VAS), and secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Official Title
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Effectiveness of M-Tapa Block for Postoperative Analgesia Management in Patients Underwent Laparoscopic Cholesistectomy

Conditions
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Cholecystitis, Cholecystitis, Acute, Cholecystitis, Chronic

Intervention / Treatment
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* Drug: M TAPA block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for laparoscopic cholesistectomy surgery under general anesthesia Exclusion Criteria: Bleeding diathesis Receiving anticoagulant treatment Known local anesthetics and opioid allergy Infection of the skin at the site of the needle puncture Pregnancy or lactation Patients who do not accept the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic cholesistectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group M = M-TAPA group, Group C = Control group) including 30 patients each, before entering the operating room.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M = M-TAPA group<br>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 100 mg tramadol will be performed for rescue analgesia. | Drug: M TAPA block<br>* Under aseptic conditions, a high frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with totally 30 ml (15 ml for each side) of %0,25 bupivacaine.<br>|
| No Intervention: Group C = Control group<br>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Wound local anesthetic infiltration will be applied to the patients in the control group. 100 mg tramadol will be performed for rescue analgesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt) | Change from Baseline Pain Scores at Postoperative 24 hours. | Postoperative 24 hours period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for rescue analgesia | The amount of Tramodol using (mg) | Postoperative 24 hours period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Cholesistectomy, M-Tapa Block, Postoperative Analgesia