Mechanical PowerNCT06202040
The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power
A study testing Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed. and Bilateral Rectus Sheath Block (RSB) will be performed. in people with Mechanical Power, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Power
- What is being tested?
- Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed. and Bilateral Rectus Sheath Block (RSB) will be performed.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2023to 25 Jan 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- ASA 1-2 patients
- Patients undergoing elective laparoscopic cholecystectomy
Who cannot join
- Mental retardation,
- Severe presence of COPD,
- Uncontrolled Bronchial Asthma,
- Decompensated Heart Failure (NYHA 3-4),
- History of previous lung surgery,
- Patients unwilling to participate in the study,
Show all 11Show fewer
- Local anesthetic allergy,
- History of chronic pain and treatment,
- Morbid obesity (body mass index (BMI) >35),
- Pregnancy,
- Patients converted to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery
The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Recently, VILI has been linked to mechanical power, or the amount of energy the mechanical ventilator sends to the respiratory system in a given time. The hunt for lung damage-reducing characteristics, notably after VILI and ARDS (Acute respiratory distress syndrome), has increased after Covid-19. Mechanical power must be used more to promote lung protection. We examined the effects of bilateral rectus sheath and OSTAP (Oblique Subcostal Transversus Abdominis Plane ) block on mechanically powered patients.
Read the detailed description
MP is the energy transmitted over time to the respiratory system during mechanical ventilation. Although mechanical ventilation is a life-supporting treatment, it has the potential to cause damage to the lung structure in a process referred to as VILI. Recently, the degree of VILI has been associated with the amount of energy transmitted to the respiratory system by the mechanical ventilator within a specific time frame, which is referred to as mechanical power. After the occurrence of Covid-19, the search for parameters to reduce lung damage, especially following VILI and ARDS, has become more prominent. In this regard, promoting lung protection requires the more widespread use of mechanical power. We aimed to investigate the effect of bilateral rectus sheath and OSTAP block applied to patients on mechanical power.
- Conditions
- Mechanical Power
- Being tested
- Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed., Bilateral Rectus Sheath Block (RSB) will be performed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.Procedure or surgery
The OSTAP block will be conducted in-plane using a 100mm 22 G needle and a linear probe under ultrasound (USG) guidance. The 20cc block will contain 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral OSTAP will be administered with 20cc (10cc per side). To apply the block, position the linear probe parallel to the rib edge immediately below it on the anterior abdominal wall. Visible will be the external, internal, transversus abdominis, and rectus muscle junction. The needle tip will move toward the TAP space (between the internal oblique and transversus abdominis muscles). To ensure medication delivery, the needle tip will be visible in the TAP and the drug will be aspirated negatively. USG will also observe drug distribution at the rectus abdominis muscle-TAP space junction.
Bilateral Rectus Sheath Block (RSB) will be performed.Procedure or surgery
When the patient is in the supine position, the ultrasound (USG) linear probe is held in the transverse plane at the level just above the umbilicus, where the posterior rectus sheath is best visualized. Using the in-plane technique with a 100mm 22 G needle under USG guidance, the drug prepared will be administered between the rectus muscle and the posterior rectus sheath. For this block, a volume of 20cc will be prepared, consisting of 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral Rectus Sheath Block (RSB) will be applied with a total volume of 20cc, 10cc to each side.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:OSTAPand RSB | Active comparator | Group 1 will consist of patients who received general anesthesia, and just before the surgery started, bilateral OSTAP and RSB will be performed. Receives: Procedure: Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.; Procedure: Bilateral Rectus Sheath Block (RSB) will be performed. |
| Group 2: Intravenous analgesia | No intervention | Group 2 will include patients who received general anesthesia and were administered intravenous analgesia approximately 30 minutes before the end of the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.
Primary outcome measures will be based on intraoperative measurements taken from the mechanical ventilator, and mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3).
Measured: Comen after intubation (before the block procedure), end of the surgery pre sugammadex administration and end of the surgery post sugammadex administration
Secondary outcomes (3)
Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).
Secondary outcome measures will include postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours, using the Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).
Measured: postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
the Quality of Recovery-15 Test (QoR-15T) [ Excellent (QoR-15 > 135 point), Good (122 ≤ QoR-15 ≤ 135 points), Moderate (90 ≤ QoR-15 ≤ 121 point), Poor (QoR-15 < 90 points) ]
Secondary outcome measures will include postoperative assessments at 24 hours, the Quality of Recovery-15 Test (QoR-15T) will be used to assess patient recovery quality.
Measured: Postoperative assessments at 24 hours
Number of rescue analgesic needs
Secondary outcome measures will include postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours, number of rescue analgesic needs will be recorded.
Measured: Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start22 Dec 2023
- Primary completion15 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical PowerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Karaarslan, Konya City Hospital
- Investigators
- Esma Karaarslan, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202040
- Sponsor's protocol ID
- MacPower
- Status last verified
- May 2024
- First submitted
- 21 Dec 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Maybe, we can share all info after finish the study.
Publications
Karaarslan E, Tire Y, Tutar MS, Akinci N, Mermer HA, Uyar S, Ates D, Simsek G, Kozanhan B. The effect of bilateral rectus sheath and oblique subcostal transversus abdominis plane blocks on mechanical power in patients undergoing laparoscopic cholecystectomy surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 16;25(1):186. doi: 10.1186/s12871-025-03062-6.
PubMed 40241019
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06202040
- Acronym / sponsor ID
- MacPower
- Conditions
- Mechanical Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 11 Jan 2024 (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.
The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Recently, VILI has been linked to mechanical power, or the amount of energy the mechanical ventilator sends to the respiratory system in a given time. The hunt for lung damage-reducing characteristics, notably after VILI and ARDS (Acute respiratory distress syndrome), has increased after Covid-19. Mechanical power must be used more to promote lung protection. We examined the effects of bilateral rectus sheath and OSTAP (Oblique Subcostal Transversus Abdominis Plane ) block on mechanically powered patients.
Detailed description
MP is the energy transmitted over time to the respiratory system during mechanical ventilation. Although mechanical ventilation is a life-supporting treatment, it has the potential to cause damage to the lung structure in a process referred to as VILI. Recently, the degree of VILI has been associated with the amount of energy transmitted to the respiratory system by the mechanical ventilator within a specific time frame, which is referred to as mechanical power. After the occurrence of Covid-19, the search for parameters to reduce lung damage, especially following VILI and ARDS, has become more prominent. In this regard, promoting lung protection requires the more widespread use of mechanical power. We aimed to investigate the effect of bilateral rectus sheath and OSTAP block applied to patients on mechanical power.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:OSTAPand RSB | Active comparator | Procedure: Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed., Procedure: Bilateral Rectus Sheath Block (RSB) will be performed.Group 1 will consist of patients who received general anesthesia, and just before the surgery started, bilateral OSTAP and RSB will be performed. |
| Group 2: Intravenous analgesia | No intervention | –Group 2 will include patients who received general anesthesia and were administered intravenous analgesia approximately 30 minutes before the end of the operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years
- ASA 1-2 patients
- Patients undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (11 listed)
- Mental retardation,
- Severe presence of COPD,
- Uncontrolled Bronchial Asthma,
- Decompensated Heart Failure (NYHA 3-4),
- History of previous lung surgery,
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 |
|---|---|---|
| Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.The OSTAP block will be conducted in-plane using a 100mm 22 G needle and a linear probe under ultrasound (USG) guidance. The 20cc block will contain 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral OSTAP will be administered with 20cc (10cc per side). To apply the block, position the linear probe parallel to the rib edge immediately below it on the anterior abdominal wall. Visible will be the external, internal, transversus abdominis, and rectus muscle junction. The needle tip will move toward the TAP space (between the internal oblique and transversus abdominis muscles). To ensure medication delivery, the needle tip will be visible in the TAP and the drug will be aspirated negatively. USG will also observe drug distribution at the rectus abdominis muscle-TAP space junction. | Procedure or surgery | Group 1:OSTAPand RSB |
| Bilateral Rectus Sheath Block (RSB) will be performed.When the patient is in the supine position, the ultrasound (USG) linear probe is held in the transverse plane at the level just above the umbilicus, where the posterior rectus sheath is best visualized. Using the in-plane technique with a 100mm 22 G needle under USG guidance, the drug prepared will be administered between the rectus muscle and the posterior rectus sheath. For this block, a volume of 20cc will be prepared, consisting of 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral Rectus Sheath Block (RSB) will be applied with a total volume of 20cc, 10cc to each side. | Procedure or surgery | Group 1:OSTAPand RSB |
Primary outcome
mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.
Time frame: Comen after intubation (before the block procedure), end of the surgery pre sugammadex administration and end of the surgery post sugammadex administration
Primary outcome measures will be based on intraoperative measurements taken from the mechanical ventilator, and mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3).
3 secondary outcomes
Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).
Time frame: postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
the Quality of Recovery-15 Test (QoR-15T) [ Excellent (QoR-15 > 135 point), Good (122 ≤ QoR-15 ≤ 135 points), Moderate (90 ≤ QoR-15 ≤ 121 point), Poor (QoR-15 < 90 points) ]
Time frame: Postoperative assessments at 24 hours
Number of rescue analgesic needs
Time frame: Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
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 23 May 2024.
- Derived from this study: PubMed 40241019Karaarslan E, Tire Y, Tutar MS, Akinci N, Mermer HA, Uyar S, Ates D, Simsek G, Kozanhan B. The effect of bilateral rectus sheath and oblique subcostal transversus abdominis plane blocks on mechanical power in patients undergoing laparoscopic cholecystectomy surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 16;25(1):186. doi: 10.1186/s12871-025-03062-6.
- Individual participant dataSharing planned: Yes. Maybe, we can share all info after finish the study.
Related trials for Mechanical Power
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
Vnotes, Respiratory Mechanics
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
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.
Esma Karaarslan, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed. and Bilateral Rectus Sheath Block (RSB) will be performed. in people with Mechanical Power, 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 11 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 23 May 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?
mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule. (time frame: Comen after intubation (before the block procedure), end of the surgery pre sugammadex administration and end of the surgery post sugammadex administration). 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 NCT06202040, which also lists 1 linked publication.
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 23 May 2024.