NCT05833113

Brief Summary

Transcutaneous Electrical Nerve Stimulation (TENS) has been reported to reduce postoperative pain scores and opioid consumption after postoperative. This study aims to evaluate the effect of TENS application on recovery quality after interscalene block for shoulder surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
Last Updated

October 31, 2024

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

April 17, 2023

Last Update Submit

October 29, 2024

Conditions

Quality of Recovery

Keywords

Interscalene brachial plexus blockTranscutaneous electrical nerve stimulationRebound pain

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 score

    Minimum value: 0, Maximum value: 150, higher scores mean better.

    Postoperative 24th hour

Secondary Outcomes (7)

  • Quality of Recovery-15 score

    postoperative day 2 and 7

  • Numerical Rating Scale

    48 hours

  • Opioid consumption

    48 hours

  • The difference of pain score before and after interscalene block resolution

    First 24 hours after interscalene block effect disappears

  • Incidence of rebound pain

    24 hours after surgery

  • +2 more secondary outcomes

Study Arms (2)

Gruop Control

PLACEBO COMPARATOR

The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative Placebo-TENS applied.

Device: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)

Group TENS

ACTIVE COMPARATOR

The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative TENS applied.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)DEVICE

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, 50 mm block needle will be advanced through the interscalene groove. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. The control group will also receive the TENS-pants electrodes, connected to TENS treatment. In the placebo-TENS applications on the painful area, 2 channels with 4 electrodes in the acute period will be applied. However, the TENS treatment to the control group will be set so that no electricity will reach the patient. A multimodal analgesia regimen will be applied postoperatively

Gruop Control
Transcutaneous Electrical Nerve Stimulation (TENS)DEVICE

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, 50 mm block needle will be advanced through the interscalene groove. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. In the TENS applications on the painful area, 2 channels with 4 electrodes in the acute period will be applied. TENS device will be applied 4 times a day with treatment periods of 30 minutes. A multimodal analgesia regimen will be applied postoperatively

Group TENS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing shoulder surgery
  • Having signed a written informed consent form,
  • ASAI-III

You may not qualify if:

  • Inadequate indication for interscalene block (Coagulation disorder, local infection of block site, Diaphragmatic paralysis, Allergy to local anesthetics)
  • Neuropathic disorder
  • Severe cardiopulmonary disease
  • Systemic steroid use
  • Chronic opioids use
  • Ucontrolled Diabetes
  • Psychiatric disorders,
  • Pregnancy,
  • Severe obesity (body mass index \> 35 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 27, 2023

Study Start

April 27, 2023

Primary Completion

March 10, 2024

Study Completion

March 24, 2024

Last Updated

October 31, 2024

Record last verified: 2023-04

Locations

TU(1)