- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744544
Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block
August 7, 2023 updated by: Samsun University
Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block in Patients Undergoing Laparoscopic Cholecystectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
External oblique block and m-Tapa blocks may be the key to provide adequate analgesia in patients undergoing abdominal surgery by blocking the abdominal nerves.
In this study, the sensory dermatome block area calculation and the regression rate of the blocks will be evaluated in patients who underwent EOIB and m-Tapa.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caner Genc, M.D.
- Phone Number: +90 5444846865
- Email: dr.canergenc@gmail.com
Study Locations
-
-
-
Samsun, Turkey
- Samsun University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing L/S cholecystectomy
Description
Inclusion Criteria:
- Patients undergoing L/S cholecystectomy
Exclusion Criteria:
- patients who do not want to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
External Oblique Intercostal Block Group
Sensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after EOIB.
(external oblique intercostal block)
|
Patients will be followed after EOIB which are routinely performed in our clinic.
|
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)
|
m-TAPA block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory Assessment on the anterolateral abdominal wall
Time Frame: 24 hours
|
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
Time Frame: 24 hours
|
Regression Rate will be performed on patients following the block procedure with pinprick test.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores (NRS) in 24 hours following surgery
Time Frame: 24 hours
|
NRS scores will be followed after surgery
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Serkan Tulgar, M.D., Samsun University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2023
Primary Completion (Actual)
August 3, 2023
Study Completion (Actual)
August 7, 2023
Study Registration Dates
First Submitted
January 16, 2023
First Submitted That Met QC Criteria
February 24, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DERMATOM55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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