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

NCT ID: NCT06202040

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-22
• Study Completion Date: 2024-01-25

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.

Conditions

Mechanical Power

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Group 1:OSTAPand RSB

Group 1 will consist of patients who received general anesthesia, and just before the surgery started, bilateral OSTAP and RSB will be performed.

Group Type: ACTIVE_COMPARATOR

Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Group 2: Intravenous analgesia

Group 2 will include patients who received general anesthesia and were administered intravenous analgesia approximately 30 minutes before the end of the operation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Esma Karaarslan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esma Karaarslan, MD

Role: PRINCIPAL_INVESTIGATOR

Konya City Hospital

Locations

Konya Cıty Hospıtal

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40241019 (View on PubMed)

Other Identifiers

MacPower

Identifier Type: -

Identifier Source: org_study_id