Clinical trial NCT06640062: Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Official title: Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Erector Spinae Plane Block
Oblique Subcostal Transversus Abdominis Plane Block
Laparoscopic Cholecystectomy
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.

Detailed description: Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.

Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 60 years.
* Both gender.
* American Society of Anesthesiologists (ASA) grade I and II physical status.
* Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
* Underwent laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient refusal.
* Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
* History of psychological disorders and/or chronic pain syndrome.
* Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
* Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) \<50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
* Severe cardiac disorders such as (heart failure).
* Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
* Advanced kidney disease (Decreased creatinine clearance \<40 ml/min).
* Pregnancy.

Primary outcomes:
measure: Degree of pain intensity
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total amount of morphine consumption
timeFrame: 24 hours postoperatively
measure: Morphine-related side effects
timeFrame: 24 hours postoperatively
measure: Local anesthetics-related side effects
timeFrame: 24 hours postoperatively
measure: Incidence of adverse effects of the block technique
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan University
state: Cairo
Study officials:
References: