NCT05827445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

August 22, 2025

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

March 27, 2023

Last Update Submit

August 18, 2025

Conditions

Keywords

Transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Related Publications (1)

  • Salmonsen CB, Lange KHW, Rothe C, Kleif J, Bertelsen CA. Cutaneous sensory block area of the laparoscopic-assisted transversus abdominis plane block. Dan Med J. 2024 Sep 9;71(10):A02240142. doi: 10.61409/A02240142.

    PMID: 39323259BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 25, 2023

Study Start

February 15, 2022

Primary Completion

October 10, 2022

Study Completion

December 31, 2022

Last Updated

August 22, 2025

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations