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Completed

NCT Number: NCT07022600

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

postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients

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Key information

Conditions

Diaphragmatic Dysfunction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

diaphragmatic ultrasound

Device

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

Primary outcomes

  1. 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

  1. Forced expiratory volume at one second

    Time frame: at baseline, 2 and 24 hours postoperatively

    FEV1 (in liter)

  2. numeric rating scale

    Time frame: at 24 hours after surgery

    score from zero to 10

  3. Forced vital capacity (in Liter)

    Time frame: at baseline, 2 hours, and 24 hours after surgery

    FVC (in liter)

  4. Peak expiratory flow rate (Liter/sec)

    Time frame: baseline, 2 hours, and 24 hours

    PEFR (Liter/sec)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Sep 18, 2025

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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