Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous nerve stimulator, Sham TENS.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery, Bariatric Surgery Candidate. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial
Overview
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
Detailed description
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.
Interventions
- Device Transcutaneous nerve stimulator
The EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs - Device Sham TENS
Electrodes will be placed identically, but no current will be delivered (sham TENS)
Primary outcome measures
- Incidence of postoperative diaphragmatic dysfunction [Time frame: 2 hours after surgery]
Secondary outcome measures (5)
- Forced vital capacity (liters) [Time frame: Before and at 2 and 24 hours postoperatively]
- Numeric rating scale [Time frame: Within 24 hours after surgery]
- Nalbuphine consumption [Time frame: 24 hours after surgery]
- Forced expiratory volume in one second (Liter) [Time frame: Before and at 2 and 24 hours]
- Peak expiratory flow rate (Liter/ second) [Time frame: Baseline, 2, and 24 hours after surgery]
Eligibility criteria
Inclusion criteria
- Body mass index > 40 kg/m2
- ASA II
Exclusion criteria
- Limited diaphragmatic ultrasound views
- Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
- Patient refusal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 2 centers
- Cairo University Hospitals — Cairo
- Cairo University Hospitals — Cairo
Publications
- 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. PMID 21483510
- 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. PMID 41188672
- 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. PMID 38546897
- 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 33295128
Identifiers
NCT: NCT07569705 · TENS and PODD in bariatric