Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block

Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane

The goal of this observational study is to assess the size and location of cutaneous sensory block area after dual laparoscopic assisted transverse abdominis plane block (L-TAP) with ropivacaine in patients undergoing laparoscopic cholecystectomy.

L-TAP is applied as a medial subcostal infiltration between midclavicular and central sternal lines and a lateral subcostal infiltration between midclavicular and anterior axillary line bilaterally.

Study Overview

• Status: Completed
• Conditions: Cholecystolithiasis

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Copenhagen University Hospital - North Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic cholecystectomy in a day surgery setting for cholecystolithiasis

Description

Inclusion Criteria:

• undergoing elective laparoscopic cholecystectomy in a day surgery setting
• able to give oral and written consent

Exclusion Criteria:

• prior surgery to the upper abdominal wall
• known sensory deficits of the abdominal wall or thorax
• allergy to local anesthetics
• pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous Sensory Block Area (CSBA)	Assessment of the CSBA was done within the duration of the cutaneous sensory effect of the laparoscopic transverse abdominis plane block. A gauze dipped in alcohol was tapped on the skin of the abdominal wall from the midsagittal line using a star-shaped approach with its center at the umbilicus to indicate cutaneous sensory changes in cold perception. Changes were marked on the skin, confirmed twice, and a connecting line drawn to determine the CSBA. The was size of the CSBA was calculated, and the location (supraumbilical or infraumbilical and medially or laterally to a vertical line through the anterior superior iliac spine.	1.5 hours postoperatively

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Transversus abdominis plane block
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: CSBA-LTAP

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