Postoperative PainCUSBATNCT05826093
Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
An observational study of Postoperative Pain, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (USTAP) at the beginning of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2022to 10 Oct 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 planned for elective laparoscopic cholecystectomy in a day surgery setting.
Who may be able to join
- Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent
Who cannot join
- Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)
- Keywords
- Transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound-guided subcostal transversus abdominis plane block (US-TAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Sensory Block Area
The area of the dermis which is blocked to sensory stimulus such as pain, heat and cold.
Measured: 90 minutes postoperatively or 150 minutes after US-TAP application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Feb 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 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 Postoperative PainStudies 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
- Investigators
- Cluas A Bertelsen, MD PhD, Study chair, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826093
- Sponsor's protocol ID
- CSBA-SUSTAP
- Acronym
- CUSBAT
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 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 ultrasound-guided subcostal transversus abdominis plane block: an observational study. Reg Anesth Pain Med. 2024 Apr 2;49(4):289-292. doi: 10.1136/rapm-2023-104753.
PubMed 37640451
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 Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT05826093
- Acronym / sponsor ID
- CUSBAT / CSBA-SUSTAP
- Conditions
- Postoperative Pain
- 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
- 10 Oct 2022 (actual)
- First posted
- 24 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients planned for cholecystectomy | – | Procedure: Ultrasound-guided subcostal transversus abdominis plane block (US-TAP)Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided transversus abdominis plane (TAP) block at the beginning of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for elective laparoscopic cholecystectomy in a day surgery setting.
Key inclusion criteria (1 listed)
- Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent
Key exclusion criteria (1 listed)
- Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients planned for cholecystectomy |
Primary outcome
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.
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 37640451Salmonsen CB, Lange KHW, Rothe C, Kleif J, Bertelsen CA. Cutaneous sensory block area of the ultrasound-guided subcostal transversus abdominis plane block: an observational study. Reg Anesth Pain Med. 2024 Apr 2;49(4):289-292. doi: 10.1136/rapm-2023-104753.
- 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.
Cluas A Bertelsen, MD PhD study chair
Copenhagen University Hospital - North Zealand
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 Postoperative Pain, 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 1 inclusion and 1 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 (time frame: 90 minutes postoperatively or 150 minutes after US-TAP application). 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 NCT05826093, 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.