M-Tapa Block for Laparoscopic Cholesistectomy

Not Applicable

Completed

• Conditions: Cholecystitis, Acute; Cholecystitis, Chronic; Cholecystitis
• Interventions: Drug: M TAPA block

• Registration Number: NCT05179629
• Lead Sponsor: Medipol University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Study Start: 2022-01-06
• Primary Completion: 2022-07-20
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M = M-TAPA group	M TAPA block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)	Postoperative 24 hours period	Change from Baseline Pain Scores at Postoperative 24 hours.

Secondary Outcome Measures

Name	Time	Method
The need for rescue analgesia	Postoperative 24 hours period	The amount of Tramodol using (mg)

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey