NCT05826093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
Last Updated

August 22, 2025

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

April 3, 2023

Last Update Submit

August 18, 2025

Conditions

Keywords

Transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Interventions

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.

Patients planned for cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients planned for elective laparoscopic cholecystectomy in a day surgery setting.

You may qualify if:

  • Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent

You may not qualify if:

  • Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 37640451BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Cluas A Bertelsen, MD PhD

    Copenhagen University Hospital - North Zealand

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 24, 2023

Study Start

February 15, 2022

Primary Completion

October 10, 2022

Study Completion

October 10, 2022

Last Updated

August 22, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations