NCT05744544

Brief Summary

External oblique and m-tapa blocks are routinely performed on patients undergoing laparoscopic cholecystectomy in our clinic. In this study, sensory block and regression rates will be investigated in patients who underwent block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

January 16, 2023

Last Update Submit

June 5, 2024

Conditions

Pain, PostoperativePain, AcutePain

Keywords

cutaneous blockSensory AssessmentRegression Rate

Outcome Measures

Primary Outcomes (2)

  • Sensory Assessment on the anterolateral abdominal wall

    Sensory Assessment will be performed on patients following the block procedure with pinprick test.

    24 hours

  • Regression Rate of the cutaneous block on anterolateral abdominal wall

    Regression Rate will be performed on patients following the block procedure with pinprick test.

    24 hours

Study Arms (2)

External Oblique Intercostal Block Group

Sensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after EOIB. (external oblique intercostal block)

Procedure: External Oblique Block

modified-TAPA block

Sensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after m-Tapa. (modified- thoracoabdominal nerves block through perichondrial approach)

Procedure: m-TAPA block

Interventions

External Oblique BlockPROCEDURE

Patients will be followed after EOIB which are routinely performed in our clinic.

External Oblique Intercostal Block Group
m-TAPA blockPROCEDURE

m-TAPA block

modified-TAPA block

Eligibility Criteria

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

Patients undergoing L/S cholecystectomy

You may qualify if:

  • Patients undergoing L/S cholecystectomy

You may not qualify if:

  • patients who do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

  • Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.

    PMID: 29278604RESULT

  • Stoving K, Rothe C, Rosenstock CV, Aasvang EK, Lundstrom LH, Lange KH. Cutaneous Sensory Block Area, Muscle-Relaxing Effect, and Block Duration of the Transversus Abdominis Plane Block: A Randomized, Blinded, and Placebo-Controlled Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):355-62. doi: 10.1097/AAP.0000000000000252.

    PMID: 25923818RESULT

MeSH Terms

Conditions

Pain, PostoperativeAcute PainPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Serkan Tulgar, M.D.

    Samsun University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 27, 2023

Study Start

May 2, 2023

Primary Completion

August 3, 2023

Study Completion

August 7, 2023

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

TU(1)