Skip to main content
Clinical Trials/NCT05207306
NCT05207306
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country60 target enrollmentApril 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain, Acute
Sponsor
Seoul National University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Maximum postoperative pain score during 12hours postoperatively
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 5, 2022
End Date
February 12, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hojin Lee, MD

Assistant clinical professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maximum postoperative pain score during 12hours postoperatively

Time Frame: at 12hour postoperatively.

maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively

Secondary Outcomes

  • Postoperative pain score at rest(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge)
  • Postoperative pain score during coughing(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge)
  • Patient satisfaction before discharge(at immediately before discharge)
  • Occurrence rate of postoperative nausea, vomiting(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.)

Study Sites (1)

Loading locations...

Similar Trials