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NCT Number: NCT06202040

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

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.

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Key information

Conditions

Mechanical Power

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya Cıty Hospıtal

Konya, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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.

  3. Number of rescue analgesic needs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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