Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block (CUSBAT)

April 11, 2023 updated by: Nordsjaellands Hospital
Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (USTAP) at the beginning of the procedure. At T90 minutes after the end of anaesthesia the cutaneous sensory block area (CSBA) was measured using cold sensation and mapped with a sterile marker. The CSBA was photodocumented and the area calculated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

  • Denmark
      • Hillerød, Denmark, 3400
        • Nordsjaellands 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients planned for elective laparoscopic cholecystectomy in a day surgery setting.

Description

Inclusion Criteria:

  • Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent

Exclusion Criteria:

  • Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients planned for cholecystectomy
Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided transversus abdominis plane (TAP) block at the beginning of the procedure.
Procedure: Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)
US-TAP is a peripheral nerve block applied for postoperative pain relief. Subcostal refers to the approach which can also be lateral or posterior. In this trial the subcostal approach was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous Sensory Block Area
Time Frame: 90 minutes postoperatively or 150 minutes after US-TAP application
The area of the dermis which is blocked to sensory stimulus such as pain, heat and cold.
90 minutes postoperatively or 150 minutes after US-TAP application

Collaborators and Investigators

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

Sponsor

Nordsjaellands Hospital

Investigators

  • Study Chair: Cluas A Bertelsen, MD PhD, Copenhagen University Hospital - North Zealand

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)

February 15, 2022

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSBA-SUSTAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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