NCT07022600

Brief Summary

postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

May 12, 2025

Last Update Submit

September 14, 2025

Conditions

Diaphragmatic Dysfunction

Keywords

erector spinae blockdiaphragmatic dysfunctionmorbidly obese

Outcome Measures

Primary Outcomes (1)

  • Incidence of diaphragmatic dysfunction in both groups

    postoperative diaphragmatic excursion 10 mm at 2 hours after surgery

    baseline and 2 hours after surgery

Secondary Outcomes (4)

  • 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

Study Arms (2)

erector spinae group

ACTIVE COMPARATOR

Patients will receive erector spinae block

Device: Diaphragmatic ultrasound

Control group

PLACEBO COMPARATOR

Patients will receive bilateral sham ultrasound-guided ESPB

Device: Diaphragmatic ultrasound

Interventions

Diaphragmatic ultrasoundDEVICE

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

Control grouperector spinae group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 39174907BACKGROUND

  • 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.

    PMID: 34325186BACKGROUND

  • 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.

    PMID: 33940248BACKGROUND

  • 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.

    PMID: 40101564BACKGROUND

  • 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.

    PMID: 33295128BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical acre

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 15, 2025

Study Start

May 27, 2025

Primary Completion

July 30, 2025

Study Completion

July 31, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

EG(1)