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

Quality of Recovery Clinical Trial

Official title:

Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833113
• Other study ID #: 03-2023/15
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: March 18, 2024

Study information

• Verified date: April 2023
• Source: Karaman Training and Research Hospital
• Contact: Tayfun Et
• Phone: 05063670717
• Email: drtayfunet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 18, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Quality of Recovery

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery-15 score	Minimum value: 0, Maximum value: 150, higher scores mean better.	Postoperative 24th hour
Secondary	Quality of Recovery-15 score	Minimum value: 0, Maximum value: 150, higher scores mean better.	postoperative day 2 and 7
Secondary	Numerical Rating Scale	Range 0-10, 0=no pain, 10=the worse pain ever.	48 hours
Secondary	Opioid consumption	Opioid consumption	48 hours
Secondary	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.	First 24 hours after interscalene block effect disappears
Secondary	Incidence of rebound pain	Rebound pain is described as severe pain (NRS = 7)	24 hours after surgery
Secondary	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.	One week after surgery
Secondary	Number of Participants with Surgical infection	Number of Participants diagnosed with surgical infection	Postoperative 14 days