Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).

Detailed Description
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Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.

Official Title
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Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study

Conditions
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Postoperative Pain, Acute

Intervention / Treatment
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* Procedure: Type of interfascial plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical classification I-II Exclusion Criteria: American Society of Anesthesiologists (ASA) physical classification III or more Chronic pain, chronic analgesic or antidepressant or anticonvulsant use Allergies to anesthetic or analgesic medications used in the protocol Single port laparoscopic cholecystectomy Patients with infection at the abdominal wall Medical or psychological disease that can affect the treatment response Do not understand our study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: A prospective randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group<br>Patients receiving right M-TAPA. | Procedure: Type of interfascial plane block<br>* In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.<br>|
| Experimental: Subcostal transversus abdominis plane block (subcostal TAPB) group<br>Patients receiving right subcostal TAPB. | Procedure: Type of interfascial plane block<br>* In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum postoperative pain score during 12hours postoperatively | maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively | at 12hour postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score at rest | Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge | 
| Postoperative pain score during coughing | Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge | 
| Patient satisfaction before discharge | Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction) | at immediately before discharge | 
| Occurrence rate of postoperative nausea, vomiting | Incidence of postoperative nausea and vomiting (%) | at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia