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Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery
Bariatric surgery is associated with several postoperative consequences, including challenging pain control, respiratory complications, and diaphragmatic dysfunction. Postoperative diaphragmatic dysfunction is defined as a diaphragmatic excursion of less than 10 mm. There is substantial evidence that diaphragmatic ultrasound provides a reliable and accurate assessment of diaphragmatic function in both intensive care unit and perioperative settings.
The present randomized controlled trial aims to evaluate the influence of transcutaneous electrical nerve stimulation on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS | Active Comparator | Three times daily for the first postoperative day, each session will last 30 minutes |
|
| Control | Sham Comparator | Electrodes will be placed identically, but no current will be delivered (sham TENS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous nerve stimulator | Device | The EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative diaphragmatic dysfunction | Diaphragmatic excursion < 10 mm 2 hours after surgery | 2 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity (liters) | is the maximum volume of air that can forcibly exhaled after taking maximum breath | Before and at 2 and 24 hours postoperatively |
| Numeric rating scale | To quantify pain from 0 to 10 (with 10 indicates worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mina Adolf Helmy, MD | Contact | 01275716942 | minaadolf1988@cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Not yet recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21483510 | Result | Tashani O, Johnson M. Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? Libyan J Med. 2009 Jun 1;4(2):62-5. doi: 10.4176/090119. | |
| 41188672 | Result | Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. 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. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4. |
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Data will be available upon reasonable request to the corresponding author after publication of the primary results.
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Application of transcutaneous electric nerve stimulator
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| Sham TENS | Device | Electrodes will be placed identically, but no current will be delivered (sham TENS) |
|
| Within 24 hours after surgery |
| Nalbuphine consumption | Total postoperative nalbuphine consumption | 24 hours after surgery |
| Forced expiratory volume in one second (Liter) | Maximum volume of air can be exhaled in the first second after maximum inspiration | Before and at 2 and 24 hours |
| Peak expiratory flow rate (Liter/ second) | Maximum flow rate during forced expiration after maximum inhalation | Baseline, 2, and 24 hours after surgery |
| Cairo University Hospitals | Recruiting | Cairo | Egypt |
|
| 38546897 | Result | Norskov J, Skaarup SH, Bendixen M, Tankisi H, Morkved AL, Juhl-Olsen P. Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery. J Anesth. 2024 Jun;38(3):386-397. doi: 10.1007/s00540-024-03325-5. Epub 2024 Mar 28. |
| 33295128 | Result | 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. |