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Clinical Trials/NCT07022600
NCT07022600CompletedNot Applicable

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.

Cairo University2 sites in 1 country80 target enrollmentStarted: May 27, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
2
Primary Endpoint
Incidence of diaphragmatic dysfunction in both groups
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

erector spinae group

Active Comparator

Patients will receive erector spinae block

Intervention: Diaphragmatic ultrasound (Device)

Control group

Placebo Comparator

Patients will receive bilateral sham ultrasound-guided ESPB

Intervention: Diaphragmatic ultrasound (Device)

Outcomes

Primary Outcomes

Incidence of diaphragmatic dysfunction in both groups

Time Frame: baseline and 2 hours after surgery

postoperative diaphragmatic excursion 10 mm at 2 hours after surgery

Secondary Outcomes

  • Forced expiratory volume at one second(at baseline, 2 and 24 hours postoperatively)
  • numeric rating scale(at 24 hours after surgery)
  • Forced vital capacity (in Liter)(at baseline, 2 hours, and 24 hours after surgery)
  • Peak expiratory flow rate (Liter/sec)(baseline, 2 hours, and 24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mina Adolf Helmy

Lecturer of anesthesia and critical acre

Cairo University

Study Sites (2)

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