Diaphragmatic DysfunctionNCT07022600
Erector Spinae Plane Block and Its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing Diaphragmatic ultrasound in people with Diaphragmatic Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diaphragmatic Dysfunction
- What is being tested?
- Diaphragmatic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morbidly obese (body mass index> 40)
- undergoing sleeve gastrectomy
Who cannot join
- allergy to bupivacaine
- respiratory comorbidities
- preoperative diaphragmatic dysfunction
- Patient refusal
- inability to adequately visualize diaphragm
Trial locations and contacts
1 site in 1 country.
About this study
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.
postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients
Read the 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)
- Conditions
- Diaphragmatic Dysfunction
- Being tested
- Diaphragmatic ultrasound
- Keywords
- erector spinae block, diaphragmatic dysfunction, morbidly obese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasoundDevice
diaphragmatic excursion will be conducted at baseline and at 2 and 24 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| erector spinae group | Active comparator | Patients will receive erector spinae block Receives: Device: Diaphragmatic ultrasound |
| Control group | Placebo comparator | Patients will receive bilateral sham ultrasound-guided ESPB Receives: Device: Diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragmatic dysfunction in both groups
postoperative diaphragmatic excursion 10 mm at 2 hours after surgery
Measured: baseline and 2 hours after surgery
Secondary outcomes (4)
Forced expiratory volume at one second
FEV1 (in liter)
Measured: at baseline, 2 and 24 hours postoperatively
numeric rating scale
score from zero to 10
Measured: at 24 hours after surgery
Forced vital capacity (in Liter)
FVC (in liter)
Measured: at baseline, 2 hours, and 24 hours after surgery
Peak expiratory flow rate (Liter/sec)
PEFR (Liter/sec)
Measured: baseline, 2 hours, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start27 May 2025
- Primary completion30 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022600
- Sponsor's protocol ID
- ESPB and its impact on DD
- Status last verified
- Sep 2025
- First submitted
- 12 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to privacy concerns, regulatory restrictions, and informed consent limitations.
Publications
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.
PubMed 39174907Yildiz 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.
PubMed 34325186Helmy 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.
PubMed 33940248Helmy 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.
PubMed 40101564Mostafa 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.
PubMed 33295128
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07022600
- Acronym / sponsor ID
- ESPB and its impact on DD
- Conditions
- Diaphragmatic Dysfunction
- Keywords
- erector spinae block, diaphragmatic dysfunction, morbidly obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae group | Active comparator | Device: Diaphragmatic ultrasoundPatients will receive erector spinae block |
| Control group | Placebo comparator | Device: Diaphragmatic ultrasoundPatients will receive bilateral sham ultrasound-guided ESPB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- morbidly obese (body mass index> 40)
- undergoing sleeve gastrectomy
Key exclusion criteria (5 listed)
- allergy to bupivacaine
- respiratory comorbidities
- preoperative diaphragmatic dysfunction
- Patient refusal
- inability to adequately visualize diaphragm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic ultrasounddiaphragmatic excursion will be conducted at baseline and at 2 and 24 hours postoperatively | Device | Control group, erector spinae group |
Primary outcome
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
4 secondary outcomes
Forced expiratory volume at one second
Time frame: at baseline, 2 and 24 hours postoperatively
numeric rating scale
Time frame: at 24 hours after surgery
Forced vital capacity (in Liter)
Time frame: at baseline, 2 hours, and 24 hours after surgery
Peak expiratory flow rate (Liter/sec)
Time frame: baseline, 2 hours, and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 39174907Helmy 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.
- Results publication: PubMed 34325186Yildiz 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.
- Results publication: PubMed 33940248Helmy 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.
- Results publication: PubMed 40101564Helmy 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.
- Results publication: PubMed 33295128Mostafa 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.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to privacy concerns, regulatory restrictions, and informed consent limitations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic ultrasound in people with Diaphragmatic Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diaphragmatic dysfunction in both groups (time frame: baseline and 2 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07022600, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.