Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients

May 17, 2026 updated by: Mina Adolf Helmy, Cairo University

Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University Hospitals
        • Contact:
      • Cairo, Egypt
        • Not yet recruiting
        • Cairo University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS
Three times daily for the first postoperative day, each session will last 30 minutes
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
Sham Comparator: Control
Electrodes will be placed identically, but no current will be delivered (sham TENS)
Device: Sham TENS
Electrodes will be placed identically, but no current will be delivered (sham TENS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative diaphragmatic dysfunction
Time Frame: 2 hours after surgery
Diaphragmatic excursion < 10 mm 2 hours after surgery
2 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced vital capacity (liters)
Time Frame: Before and at 2 and 24 hours postoperatively
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
Time Frame: Within 24 hours after surgery
To quantify pain from 0 to 10 (with 10 indicates worst pain)
Within 24 hours after surgery
Nalbuphine consumption
Time Frame: 24 hours after surgery
Total postoperative nalbuphine consumption
24 hours after surgery
Forced expiratory volume in one second (Liter)
Time Frame: Before and at 2 and 24 hours
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)
Time Frame: Baseline, 2, and 24 hours after surgery
Maximum flow rate during forced expiration after maximum inhalation
Baseline, 2, and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

May 2, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TENS and PODD in bariatric

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon reasonable request to the corresponding author after publication of the primary results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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