Anesthesia, GeneralNCT04997655
The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness
An observational study of Anesthesia, General, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the study, patients of both sexes between the ages of 18 and 60 who will undergo laparoscopic cholecystectomy will be examined. In this patient group, the change in the inspiratory and expiratory diaphragmatic thickness before and after laparoscopic cholecystectomy operation in the upper transabdominal block group… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Ultrasound measurement
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2022to 18 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: With the calculated sample size values, we will need to include at least 68 patients in our study at 0.5 sensitivity and 0.95 power.
Who may be able to join
- Patients between the ages of 18-60
- Both sexes
- Patiets are evaluated as ASA 1 and ASA 2 anesthesia risk, will be examined.
Who cannot join
- Under 18 years old, over 60 years old
- BMI>35 kg/m2
- Bleeding diathesis
- Local anesthetic allergy
- Infection in the area of TAP (Trans abdominal plane) block application
- Illiteracy, communication problem
Show all 10Show fewer
- Previous upper abdomen operation
- Transition to open surgery Cases
- Severe chronic respiratory disease
- Neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness in Adult Patients After Laparoscopic Cholecystectomy Operation
In the study, patients of both sexes between the ages of 18 and 60 who will undergo laparoscopic cholecystectomy will be examined. In this patient group, the change in the inspiratory and expiratory diaphragmatic thickness before and after laparoscopic cholecystectomy operation in the upper transabdominal block group will be examined.
Read the detailed description
The use of ultrasonography (USG) in operating rooms is increasing day by day. Diaphragm thickness can be evaluated by ultrasonography and is used as a bedside method studies have proven that the evaluation of diaphragmatic thickness contributes to the observation of diaphragmatic function and the evaluation of respiratory workload. Measurement of diaphragmatic thickness is a method used in operating rooms and intensive care units to make the decision to wean from mechanical ventilation and extubation. Laparoscopic gallbladder operations are a very common operation in the adult age group in the operating room. In these cases who were intubated and extubated at the end of the operation, regression in respiratory function is observed, especially due to right upper quadrant pain appropriate to the location of the liver. For this reason, the respiratory functions of patients who will have gallbladder surgery will be routinely evaluated before and after gallbladder surgery in our clinic with the help of USG and routinely apply analgesic methods, including peripheral nerve blocks, to patients with pain.
In this study, it will be planned to observe the effect of upper transabdominal area block, which is routinely performed post-operatively in laparoscopic gallbladder operations, on diaphragmatic thickness and therefore on respiratory capacity, and observationally evaluating diaphragmatic thickness measurements by USG, which is routinely performed post-operatively and the measurement records are noted.
- Conditions
- Anesthesia, General
- Being tested
- Ultrasound measurement
- Keywords
- Laparoscopic Cholecystectomy Operation, Diaphragm Thickness, Upper Transabdominal Plain Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementDiagnostic test
In the patient group who will undergo elective laparoscopic cholecystectomy, the diaphragmatic thickness values measured and recorded routinely at the pre-operative, post-extubation and post-operative 30th minute, at the end of inspiration and expiration, and the inspiratory amplitude in m-mode in the ultrasound measured from the right anterior axillary line subcostal area were observed as observational data. will be saved in our file.
| Study group | Role | What they receive |
|---|---|---|
| Upper Transabdominal Plain Block | All patients in this group are routinely administered general anesthesia. After extubation, the subcostal transverse abdominis area block was directed laterally along the rectus abdominis muscle by finding the linea alba under the xiphoid region under ultrasound guidance with a 22G echogenic block needle, and 20 ml (8 ml 0.5% bupivacaine, 7 ml prilocaine) into the fascia between the rectus abdominis and transverse abdominis muscles. , 5 ml of saline) drug mixture will be performed by the anesthesiologist in charge of that day, who is not aware of the observational measurement to be made, if there is an indication, as a blind practitioner. Receives: Diagnostic Test: Ultrasound measurement | |
| Opioid analgesia | All patients in this group are routinely administered general anesthesia. Apart from this, in the other group, which does not have peripheral nerve block and only routine opioid analgesia is considered sufficient, only routine peroperative USG diaphragm measurements will be recorded observationally. Receives: Diagnostic Test: Ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness
The measurement of Diaphragm Thickness by USG
Measured: 5 minutes before general anesthesia
Diaphragm Thickness
The measurement of Diaphragm Thickness by USG
Measured: 5 minutes after surgery
Diaphragm Thickness
The measurement of Diaphragm Thickness by USG
Measured: 5 minutes after upper abdominal plane block
Secondary outcomes (2)
Oxygen saturation
Oxygen saturation separately for each primary outcome stage
Measured: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
Visual analogue scale
The patient's pain will be asked in a scale from 1 to 10.
Measured: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start2 Jun 2022
- Primary completion1 Sep 2022
- Study completion18 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
- Investigators
- Yasin Tire, Study director, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997655
- Sponsor's protocol ID
- KonyaCityH
- Status last verified
- Mar 2023
- First submitted
- 25 Jul 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I plan to make individual participant data (IPD) available to only responsible researchers.
Publications
Vivier E, Muller M, Putegnat JB, Steyer J, Barrau S, Boissier F, Bourdin G, Mekontso-Dessap A, Levrat A, Pommier C, Thille AW. Inability of Diaphragm Ultrasound to Predict Extubation Failure: A Multicenter Study. Chest. 2019 Jun;155(6):1131-1139. doi: 10.1016/j.chest.2019.03.004. Epub 2019 Mar 23.
PubMed 30910636DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
PubMed 24365607Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682.
PubMed 31876624
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Transabdominal Plain Block on Diaphragm Thickness in Adult Patients After Laparoscopic Cholecystectomy Operation
- ClinicalTrials.gov ID
- NCT04997655
- Acronym / sponsor ID
- KonyaCityH
- Conditions
- Anesthesia, General
- Keywords
- Laparoscopic Cholecystectomy Operation, Diaphragm Thickness, Upper Transabdominal Plain Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 9 Aug 2021 (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.
In the study, patients of both sexes between the ages of 18 and 60 who will undergo laparoscopic cholecystectomy will be examined. In this patient group, the change in the inspiratory and expiratory diaphragmatic thickness before and after laparoscopic cholecystectomy operation in the upper transabdominal block group will be examined.
Detailed description
The use of ultrasonography (USG) in operating rooms is increasing day by day. Diaphragm thickness can be evaluated by ultrasonography and is used as a bedside method studies have proven that the evaluation of diaphragmatic thickness contributes to the observation of diaphragmatic function and the evaluation of respiratory workload. Measurement of diaphragmatic thickness is a method used in operating rooms and intensive care units to make the decision to wean from mechanical ventilation and extubation. Laparoscopic gallbladder operations are a very common operation in the adult age group in the operating room. In these cases who were intubated and extubated at the end of the operation, regression in respiratory function is observed, especially due to right upper quadrant pain appropriate to the location of the liver. For this reason, the respiratory functions of patients who will have gallbladder surgery will be routinely evaluated before and after gallbladder surgery in our clinic with the help of USG and routinely apply analgesic methods, including peripheral nerve blocks, to patients with pain.
In this study, it will be planned to observe the effect of upper transabdominal area block, which is routinely performed post-operatively in laparoscopic gallbladder operations, on diaphragmatic thickness and therefore on respiratory capacity, and observationally evaluating diaphragmatic thickness measurements by USG, which is routinely performed post-operatively and the measurement records are noted.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Transabdominal Plain Block | – | Diagnostic Test: Ultrasound measurementAll patients in this group are routinely administered general anesthesia. After extubation, the subcostal transverse abdominis area block was directed laterally along the rectus abdominis muscle by finding the linea alba under the xiphoid region under ultrasound guidance with a 22G echogenic block needle, and 20 ml (8 ml 0.5% bupivacaine, 7 ml prilocaine) into the fascia between the rectus abdominis and transverse abdominis muscles. , 5 ml of saline) drug mixture will be performed by the anesthesiologist in charge of that day, who is not aware of the observational measurement to be made, if there is an indication, as a blind practitioner. |
| Opioid analgesia | – | Diagnostic Test: Ultrasound measurementAll patients in this group are routinely administered general anesthesia. Apart from this, in the other group, which does not have peripheral nerve block and only routine opioid analgesia is considered sufficient, only routine peroperative USG diaphragm measurements will be recorded observationally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- With the calculated sample size values, we will need to include at least 68 patients in our study at 0.5 sensitivity and 0.95 power.
Key inclusion criteria (3 listed)
- Patients between the ages of 18-60
- Both sexes
- Patiets are evaluated as ASA 1 and ASA 2 anesthesia risk, will be examined.
Key exclusion criteria (10 listed)
- Under 18 years old, over 60 years old
- BMI>35 kg/m2
- Bleeding diathesis
- Local anesthetic allergy
- Infection in the area of TAP (Trans abdominal plane) block application
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 |
|---|---|---|
| Ultrasound measurementIn the patient group who will undergo elective laparoscopic cholecystectomy, the diaphragmatic thickness values measured and recorded routinely at the pre-operative, post-extubation and post-operative 30th minute, at the end of inspiration and expiration, and the inspiratory amplitude in m-mode in the ultrasound measured from the right anterior axillary line subcostal area were observed as observational data. will be saved in our file. | Diagnostic test | Opioid analgesia, Upper Transabdominal Plain Block |
Primary outcome
Diaphragm Thickness
Time frame: 5 minutes before general anesthesia
The measurement of Diaphragm Thickness by USG
Diaphragm Thickness
Time frame: 5 minutes after surgery
The measurement of Diaphragm Thickness by USG
Diaphragm Thickness
Time frame: 5 minutes after upper abdominal plane block
The measurement of Diaphragm Thickness by USG
2 secondary outcomes
Oxygen saturation
Time frame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
Visual analogue scale
Time frame: Before the anesthesia, after anesthesia and after 30 minutes in the post operative care unit.
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 21 Mar 2023.
- Background: PubMed 30910636Vivier E, Muller M, Putegnat JB, Steyer J, Barrau S, Boissier F, Bourdin G, Mekontso-Dessap A, Levrat A, Pommier C, Thille AW. Inability of Diaphragm Ultrasound to Predict Extubation Failure: A Multicenter Study. Chest. 2019 Jun;155(6):1131-1139. doi: 10.1016/j.chest.2019.03.004. Epub 2019 Mar 23.
- Results publication: PubMed 24365607DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
- Results publication: PubMed 31876624Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682.
- Gülleroğlu, Aykan, et al. "Laparoskopik kolesistektomi operasyonlarında karın içi basınç artışının solunum mekaniği, hemodinami ve metabolizma üzerindeki etkileri." Ok Meydanı Eğitim ve Araştırma Hastanesi Anesteziyoloji ve Reanimasyon KliLink provided by the sponsor.
- Andıç, K. D., N. Göğüş, and Ayşe Lafcı. "Laparoskopik Kolesistektomi Geçiren Hastalarda Ultrasonografi Eşliğinde Uygulanan Transversus Abdominis Plan Bloğun Perioperatif Analjezi ve Hasta Konforuna Katkısı." (2021).Link provided by the sponsor.
- Individual participant dataSharing planned: No. I plan to make individual participant data (IPD) available to only responsible researchers.
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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.
Yasin Tire study director
Konya City Hospital
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 Anesthesia, General, run by Konya City Hospital 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 3 inclusion and 10 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 21 Mar 2023. 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?
Diaphragm Thickness (time frame: 5 minutes before general anesthesia). The study lists 3 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 NCT04997655, which also lists 3 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 21 Mar 2023.