Clinical trial NCT07022600: Erector Spinae Plane Block and Its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official title: Erector Spinae Plane Block and Its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy, A Double-blind Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diaphragmatic Dysfunction
Keywords: erector spinae block
diaphragmatic dysfunction
morbidly obese
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients

Detailed description: Investigators aimed to evaluate the impact of erector spinae plane block on the incidence of postoperative diaphragmatic dysfunction in morbidly obese patients (Body mass index more than or equal 40)

Eligibility criteria: Inclusion Criteria:

* morbidly obese (body mass index\> 40)
* undergoing sleeve gastrectomy

Exclusion Criteria:

* allergy to bupivacaine
* respiratory comorbidities
* preoperative diaphragmatic dysfunction
* Patient refusal
* inability to adequately visualize diaphragm

Primary outcomes:
measure: Incidence of diaphragmatic dysfunction in both groups
timeFrame: baseline and 2 hours after surgery
Secondary outcomes:
measure: Forced expiratory volume at one second
timeFrame: at baseline, 2 and 24 hours postoperatively
measure: numeric rating scale
timeFrame: at 24 hours after surgery
measure: Forced vital capacity (in Liter)
timeFrame: at baseline, 2 hours, and 24 hours after surgery
measure: Peak expiratory flow rate (Liter/sec)
timeFrame: baseline, 2 hours, and 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Cairo Governorate
city: Cairo
country: Egypt
facility: Cairo University
state: Cairo Governorate
Study officials:
References:
citation: Helmy MA, Hasanin A, Milad LM, Mostafa M, Hamimy WI, Muhareb RS, Raafat H. Ability of parasternal intercostal muscle thickening fraction to predict reintubation in surgical patients with sepsis. BMC Anesthesiol. 2024 Aug 22;24(1):294. doi: 10.1186/s12871-024-02666-8.
citation: Yildiz M, Kozanhan B, Iyisoy MS, Canitez A, Aksoy N, Eryigit A. The effect of erector spinae plane block on postoperative analgesia and respiratory function in patients undergoing laparoscopic cholecystectomy: A double-blind randomized controlled trial. J Clin Anesth. 2021 Nov;74:110403. doi: 10.1016/j.jclinane.2021.110403. Epub 2021 Jul 26.
citation: Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.
citation: Helmy MA, Mostafa L, El-Zayyat NS, Ali MA, Sabry R. Impaired diaphragmatic excursion following magnesium sulfate administration in patients with preeclampsia with severe features: a prospective observational study. Int J Obstet Anesth. 2025 May;62:104347. doi: 10.1016/j.ijoa.2025.104347. Epub 2025 Feb 28.
citation: Mostafa SF, Abdelghany MS, Abu Elyazed MM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Trial. Pain Pract. 2021 Apr;21(4):445-453. doi: 10.1111/papr.12975. Epub 2021 Jan 22.