Clinical trial NCT06202040: The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power
Official title: The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Power
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 65 years
* ASA 1-2 patients
* Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* 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,
* Local anesthetic allergy,
* History of chronic pain and treatment,
* Morbid obesity (body mass index (BMI) \>35),
* Pregnancy,
* Patients converted to open cholecystectomy

Primary outcomes:
measure: mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.
timeFrame: Comen after intubation (before the block procedure), end of the surgery pre sugammadex administration and end of the surgery post sugammadex administration
Secondary outcomes:
measure: Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).
timeFrame: postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
measure: 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) ]
timeFrame: Postoperative assessments at 24 hours
measure: Number of rescue analgesic needs
timeFrame: Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Cıty Hospıtal
Study officials:
affiliation: Konya City Hospital
name: Esma Karaarslan, MD
role: PRINCIPAL_INVESTIGATOR
References: