Pain, PostoperativeNCT05744544
Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block
An observational study of Pain, Postoperative and Pain, Acute, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain
- What is being tested?
- External Oblique Block and m-TAPA block
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 7 Aug 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing L/S cholecystectomy
Who may be able to join
- Patients undergoing L/S cholecystectomy
Who cannot join
- patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain
- Being tested
- External Oblique Block, m-TAPA block
- Keywords
- cutaneous block, Sensory Assessment, Regression Rate
- Medical subject headings
- Pain, Postoperative, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique BlockProcedure or surgery
Patients will be followed after EOIB which are routinely performed in our clinic.
m-TAPA blockProcedure or surgery
m-TAPA block
| Study group | Role | What they receive |
|---|---|---|
| External Oblique Intercostal Block Group | Sensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after EOIB. (external oblique intercostal block) Receives: 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) Receives: Procedure: m-TAPA block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Assessment on the anterolateral abdominal wall
Sensory Assessment will be performed on patients following the block procedure with pinprick test.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start2 May 2023
- Primary completion3 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Tulgar, M.D., Study chair, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744544
- Sponsor's protocol ID
- DERMATOM55
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29278604Stoving 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.
PubMed 25923818
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05744544
- Acronym / sponsor ID
- DERMATOM55
- Conditions
- Pain, Postoperative, Pain, Acute, Pain
- Keywords
- cutaneous block, Sensory Assessment, Regression Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Oblique Intercostal Block Group | – | Procedure: External Oblique BlockSensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after EOIB. (external oblique intercostal block) |
| modified-TAPA block | – | Procedure: m-TAPA blockSensory Assessment and Regression Rate will be performed on the anterolateral abdominal wall after m-Tapa. (modified- thoracoabdominal nerves block through perichondrial approach) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing L/S cholecystectomy
Key inclusion criteria (1 listed)
- Patients undergoing L/S cholecystectomy
Key exclusion criteria (1 listed)
- patients who do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Oblique BlockPatients will be followed after EOIB which are routinely performed in our clinic. | Procedure or surgery | External Oblique Intercostal Block Group |
| m-TAPA blockm-TAPA block | Procedure or surgery | modified-TAPA block |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Results publication: PubMed 29278604Chen 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.
- Results publication: PubMed 25923818Stoving 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Tulgar, M.D. study chair
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Pain, Acute, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Assessment on the anterolateral abdominal wall (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.