CholecystolithiasisNCT05827445
Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block
An observational study of Cholecystolithiasis, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystolithiasis
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic cholecystectomy in a day surgery setting for cholecystolithiasis
Who may be able to join
- undergoing elective laparoscopic cholecystectomy in a day surgery setting
- able to give oral and written consent
Who cannot join
- prior surgery to the upper abdominal wall
- known sensory deficits of the abdominal wall or thorax
- allergy to local anesthetics
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cholecystolithiasis
- Keywords
- Transversus abdominis plane block
- Medical subject headings
- Cholecystolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Feb 2022
- Primary completion10 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827445
- Sponsor's protocol ID
- CSBA-LTAP
- Status last verified
- Oct 2022
- First submitted
- 27 Mar 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39323259
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane
- ClinicalTrials.gov ID
- NCT05827445
- Acronym / sponsor ID
- CSBA-LTAP
- Conditions
- Cholecystolithiasis
- Keywords
- Transversus abdominis plane block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic cholecystectomy in a day surgery setting for cholecystolithiasis
Key inclusion criteria (2 listed)
- undergoing elective laparoscopic cholecystectomy in a day surgery setting
- able to give oral and written consent
Key exclusion criteria (4 listed)
- prior surgery to the upper abdominal wall
- known sensory deficits of the abdominal wall or thorax
- allergy to local anesthetics
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cutaneous Sensory Block Area (CSBA)
Time frame: 1.5 hours postoperatively
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 39323259Salmonsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystolithiasis, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Sensory Block Area (CSBA) (time frame: 1.5 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.