CUSBAT: Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
Sponsor
Nordsjaellands Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05826093
Collaborator
(none)
30
1
7.8
3.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block
Actual Study Start Date
:
Feb 15, 2022
Actual Primary Completion Date
:
Oct 10, 2022
Actual Study Completion Date
:
Oct 10, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Cutaneous Sensory Block Area [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nordsjaellands Hospital | Hillerød | Denmark | 3400 |
Sponsors and Collaborators
- Nordsjaellands Hospital
Investigators
- Study Chair: Cluas A Bertelsen, MD PhD, Copenhagen University Hospital - North Zealand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nordsjaellands Hospital
ClinicalTrials.gov Identifier:
NCT05826093
Other Study ID Numbers:
- CSBA-SUSTAP
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nordsjaellands Hospital
Additional relevant MeSH terms: