Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

N/ACompletedNCT05207306

Seoul National University Hospital60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain, Acute

Interventions

Type of interfascial plane blockPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Please Select An Option, South Korea

Outcomes

Primary Outcomes

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

Time frame: at 12hour postoperatively.

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: at immediately before discharge

Occurrence rate of postoperative nausea, vomiting

Incidence of postoperative nausea and vomiting (%)

Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.

Data from ClinicalTrials.gov

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