Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

August 20, 2023 updated by: Hojin Lee, MD, Seoul National University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Please Select An Option
      • Seoul, Please Select An Option, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group
Patients receiving right M-TAPA.
Procedure: Type of interfascial plane block

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.
Experimental: Subcostal transversus abdominis plane block (subcostal TAPB) group
Patients receiving right subcostal TAPB.
Procedure: Type of interfascial plane block

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 12hour postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score at rest
Time Frame: 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
at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Postoperative pain score during coughing
Time Frame: 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
at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Patient satisfaction before discharge
Time Frame: at immediately 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
Time Frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.
Incidence of postoperative nausea and vomiting (%)
at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Hojin Lee, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

February 12, 2023

Study Completion (Actual)

February 12, 2023

Study Registration Dates

First Submitted

January 2, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 20, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2111-040-1270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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