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

Karaman Training and Research Hospital80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Quality of Recovery

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Outcomes

Primary Outcomes

Quality of Recovery-15 score

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

Time frame: Postoperative 24th hour

Secondary Outcomes

Quality of Recovery-15 score

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

Time frame: postoperative day 2 and 7

Numerical Rating Scale

Range 0-10, 0=no pain, 10=the worse pain ever.

Time frame: 48 hours

Opioid consumption

Time frame: 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.

Time frame: First 24 hours after interscalene block effect disappears

Incidence of rebound pain

Rebound pain is described as severe pain (NRS ≥ 7)

Time frame: 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.

Time frame: One week after surgery

Number of Participants with Surgical infection

Data from ClinicalTrials.gov

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