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Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery

Primary Purpose

Quality of Recovery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)
Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Recovery focused on measuring Interscalene brachial plexus block, Transcutaneous electrical nerve stimulation, Rebound pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Undergoing shoulder surgery Having signed a written informed consent form, ASAI-III Exclusion Criteria: 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)

Sites / Locations

  • Karaman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Gruop Control

Group TENS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.

Secondary Outcome Measures

Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Numerical Rating Scale
Range 0-10, 0=no pain, 10=the worse pain ever.
Opioid consumption
Opioid consumption
The difference of pain score before and after interscalene block resolution
The difference in the pain score between when the block is working and when it has resolved. Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.
Incidence of rebound pain
Rebound pain is described as severe pain (NRS ≥ 7)
Sleep Quality measured with Likert Scale
Patients' perceived sleep quality will be assessed with a Likert scale. Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied.
Number of Participants with Surgical infection
Number of Participants diagnosed with surgical infection

Full Information

First Posted
April 17, 2023
Last Updated
September 27, 2023
Sponsor
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05833113
Brief Title
Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery
Official Title
Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Shoulder rotator cuff repair and acromioplasty are associated with severe pain after surgery. Interscalene block (ISB) is the gold standard for shoulder surgery, but the block duration does not exceed 6-8 hours. In addition, after the resolution of ISB, patients experience severe pain and need high doses of opioids. Rebound pain is observed in the postoperative period after the effect of the nerve block abolition. Rebound pain affects the quality of recovery and sleep quality in postoperative. Transcutaneous Electrical Nerve Stimulation (TENS) is a method of pain relief that uses cutaneously applied electrodes for delivering electrical signals to peripheral nerves through the intact skin. TENS is safe and effective for acute postoperative pain treatment. In addition, TENS has been used in anesthesia to treat postoperative nausea vomiting, and labor analgesia beyond providing analgesia. We hypothesized that TENS application would reduce the incidence of rebound pain, reduce the need for postoperative opioids, and improve recovery and sleep quality. This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Recovery
Keywords
Interscalene brachial plexus block, Transcutaneous electrical nerve stimulation, Rebound pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gruop Control
Arm Type
Placebo Comparator
Arm Description
The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative Placebo-TENS applied.
Arm Title
Group TENS
Arm Type
Active Comparator
Arm Description
The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative TENS applied.
Intervention Type
Device
Intervention Name(s)
Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of Recovery-15 score
Description
Minimum value: 0, Maximum value: 150, higher scores mean better.
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Quality of Recovery-15 score
Description
Minimum value: 0, Maximum value: 150, higher scores mean better.
Time Frame
postoperative day 2 and 7
Title
Numerical Rating Scale
Description
Range 0-10, 0=no pain, 10=the worse pain ever.
Time Frame
48 hours
Title
Opioid consumption
Description
Opioid consumption
Time Frame
48 hours
Title
The difference of pain score before and after interscalene block resolution
Description
The difference in the pain score between when the block is working and when it has resolved. Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.
Time Frame
First 24 hours after interscalene block effect disappears
Title
Incidence of rebound pain
Description
Rebound pain is described as severe pain (NRS ≥ 7)
Time Frame
24 hours after surgery
Title
Sleep Quality measured with Likert Scale
Description
Patients' perceived sleep quality will be assessed with a Likert scale. Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied.
Time Frame
One week after surgery
Title
Number of Participants with Surgical infection
Description
Number of Participants diagnosed with surgical infection
Time Frame
Postoperative 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Undergoing shoulder surgery Having signed a written informed consent form, ASAI-III Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayfun Et
Phone
05063670717
Email
drtayfunet@gmail.com
Facility Information:
Facility Name
Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tayfun Et, MD
Phone
+905063670717
Email
drtayfunet@gmail.com
First Name & Middle Initial & Last Name & Degree
Betul Basaran, MD,DESA,Prof
Phone
+905325056402
Email
betulbasaran1@yahoo.com

12. IPD Sharing Statement

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Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery

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