NCT07569705

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

April 26, 2026

Last Update Submit

May 2, 2026

Conditions

Bariatric SurgeryBariatric Surgery Candidate

Keywords

BariatricDiaphragmatic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative diaphragmatic dysfunction

    Diaphragmatic excursion \< 10 mm 2 hours after surgery

    2 hours after surgery

Secondary Outcomes (5)

  • Forced vital capacity (liters)

    Before and at 2 and 24 hours postoperatively

  • Numeric rating scale

    Within 24 hours after surgery

  • Nalbuphine consumption

    24 hours after surgery

  • Forced expiratory volume in one second (Liter)

    Before and at 2 and 24 hours

  • Peak expiratory flow rate (Liter/ second)

    Baseline, 2, and 24 hours after surgery

Study Arms (2)

TENS

ACTIVE COMPARATOR

Three times daily for the first postoperative day, each session will last 30 minutes

Device: Transcutaneous nerve stimulator

Control

SHAM COMPARATOR

Electrodes will be placed identically, but no current will be delivered (sham TENS)

Device: Sham TENS

Interventions

Sham TENSDEVICE

Electrodes will be placed identically, but no current will be delivered (sham TENS)

Control
Transcutaneous nerve stimulatorDEVICE

The EM49 will be set to a TENS program with a frequency of 80-100 Hz and a pulse width of 200 μs

TENS

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \> 40 kg/m2
  • ASA II

You may not qualify if:

  • Limited diaphragmatic ultrasound views
  • Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (4)

  • 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: 21483510RESULT

  • 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: 41188672RESULT

  • 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: 38546897RESULT

  • 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: 33295128RESULT

Central Study Contacts

Mina Adolf Helmy, MD

CONTACT

01275716942minaadolf1988@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Application of transcutaneous electric nerve stimulator
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 6, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations

EG(1)