Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute
• Interventions: Procedure: Type of interfascial plane block

• Registration Number: NCT05207306
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-01-02
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2022-04-05
• Primary Completion: 2023-02-12
• Study Completion: 2023-02-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcostal transversus abdominis plane block (subcostal TAPB) group	Type of interfascial plane block	Patients receiving right subcostal TAPB.
Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group	Type of interfascial plane block	Patients receiving right M-TAPA.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Please Select An Option, Korea, Republic of