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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05826093
Other study ID # CSBA-SUSTAP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date October 10, 2022

Study information

Verified date April 2023
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 10, 2022
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Denmark Nordsjaellands Hospital Hillerød

Sponsors (1)

Lead Sponsor Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cutaneous Sensory Block Area 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
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