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

Karaman Training and Research Hospital

Status: Completed

Conditions: Quality of Recovery

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05833113

03-2023/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Gruop Control

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS)

Group TENS

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)