The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power

Not Applicable

Completed

• Conditions: Mechanical Power
• Interventions: Procedure: Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.; Procedure: Bilateral Rectus Sheath Block (RSB) will be performed.

• Registration Number: NCT06202040
• Lead Sponsor: Konya City Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Study Start: 2023-12-22
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-11
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1:OSTAPand RSB	Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) 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 1:OSTAPand RSB	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.

Primary Outcome Measures

Name	Time	Method
mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.	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).

Secondary Outcome Measures

Name	Time	Method
Number of rescue analgesic needs	Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours	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.
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) ]	Postoperative assessments at 24 hours	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.
Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).	postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours	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).

Trial Locations

Locations (1)

Konya Cıty Hospıtal; 🇹🇷 Konya, Turkey