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

NCT06202040 | Completed

• 1 other identifier: MacPower
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Power

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  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) ]

  Postoperative assessments at 24 hours

• Number of rescue analgesic needs

  Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours

Study Arms (2)

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.

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.

Interventions

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

Group 1:OSTAPand RSB

Bilateral Rectus Sheath Block (RSB) will be performed. 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 1:OSTAPand RSB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya Cıty Hospıtal

Konya, 42020, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40241019 DERIVED

Study Officials

• Esma Karaarslan, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 11, 2024
• Study Start: December 22, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 25, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We want to descrıbe time frame after finish the study.
• Access Criteria: We can share the data by usın e-mail.

Locations

TU (1)