Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block

Cholecystolithiasis Clinical Trial

Official title:

Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827445
• Other study ID #: CSBA-LTAP
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - North Zealand	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 (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