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Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

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Seoul National University

Status

Completed

Conditions

Postoperative Pain, Acute

Treatments

Procedure: Type of interfascial plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT05207306
2111-040-1270

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hye-yeon Cho, MD; Hojin Lee, MD

Data sourced from clinicaltrials.gov

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