Erector Spinae Plane Block and Its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT ID: NCT07022600

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2025-07-31

Brief Summary

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postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients

Detailed Description

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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)

Conditions

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Diaphragmatic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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erector spinae group

Patients will receive erector spinae block

Group Type ACTIVE_COMPARATOR

Diaphragmatic ultrasound

Intervention Type DEVICE

diaphragmatic excursion will be conducted at baseline and at 2 and 24 hours postoperatively

Control group

Patients will receive bilateral sham ultrasound-guided ESPB

Group Type PLACEBO_COMPARATOR

Diaphragmatic ultrasound

Intervention Type DEVICE

diaphragmatic excursion will be conducted at baseline and at 2 and 24 hours postoperatively

Interventions

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Diaphragmatic ultrasound

diaphragmatic excursion will be conducted at baseline and at 2 and 24 hours postoperatively

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mina Adolf Helmy

Lecturer of anesthesia and critical acre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 39174907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34325186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33940248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40101564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33295128 (View on PubMed)

Other Identifiers

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ESPB and its impact on DD

Identifier Type: -

Identifier Source: org_study_id

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