Quality of RecoveryNCT05833113
Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Quality of Recovery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2023to 24 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing shoulder surgery
- Having signed a written informed consent form,
- ASAI-III
Who cannot join
- 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
Show all 9Show fewer
- Psychiatric disorders,
- Pregnancy,
- Severe obesity (body mass index > 35 kg/m2)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Quality of Recovery
- Being tested
- Placebo-Transcutaneous Electrical Nerve Stimulation (TENS), Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Interscalene brachial plexus block, Transcutaneous electrical nerve stimulation, Rebound pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Gruop Control | Placebo comparator | The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative Placebo-TENS applied. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Measured: Postoperative 24th hour
Secondary outcomes (7)
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Measured: postoperative day 2 and 7
Numerical Rating Scale
Range 0-10, 0=no pain, 10=the worse pain ever.
Measured: 48 hours
Opioid consumption
Opioid consumption
Measured: 48 hours
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.
Measured: First 24 hours after interscalene block effect disappears
Incidence of rebound pain
Rebound pain is described as severe pain (NRS ≥ 7)
Measured: 24 hours after surgery
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.
Measured: One week after surgery
Number of Participants with Surgical infection
Number of Participants diagnosed with surgical infection
Measured: Postoperative 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start27 Apr 2023
- Primary completion10 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833113
- Sponsor's protocol ID
- 03-2023/15
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05833113
- Acronym / sponsor ID
- 03-2023/15
- Conditions
- Quality of Recovery
- Keywords
- Interscalene brachial plexus block, Transcutaneous electrical nerve stimulation, Rebound pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gruop Control | Placebo comparator | Device: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative Placebo-TENS applied. |
| Group TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative TENS applied. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing shoulder surgery
- Having signed a written informed consent form,
- ASAI-III
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)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 | Device | Gruop Control |
| Transcutaneous Electrical Nerve Stimulation (TENS)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 | Device | Group TENS |
Primary outcome
Quality of Recovery-15 score
Time frame: Postoperative 24th hour
Minimum value: 0, Maximum value: 150, higher scores mean better.
7 secondary outcomes
Quality of Recovery-15 score
Time frame: postoperative day 2 and 7
Numerical Rating Scale
Time frame: 48 hours
Opioid consumption
Time frame: 48 hours
The difference of pain score before and after interscalene block resolution
Time frame: First 24 hours after interscalene block effect disappears
Incidence of rebound pain
Time frame: 24 hours after surgery
Sleep Quality measured with Likert Scale
Time frame: One week after surgery
Number of Participants with Surgical infection
Time frame: Postoperative 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Quality of Recovery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 score (time frame: Postoperative 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.