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

Not Applicable

Completed

• Conditions: Quality of Recovery
• Interventions: Device: Placebo-Transcutaneous Electrical Nerve Stimulation (TENS); Device: Transcutaneous Electrical Nerve Stimulation (TENS)

• Registration Number: NCT05833113
• Lead Sponsor: Karaman Training and Research Hospital

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study Start: 2023-04-27
• Study First Posted: 2023-04-27
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-24
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gruop Control	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	Transcutaneous Electrical Nerve Stimulation (TENS)	The patients will be received an ultrasound-guided interscalene brachial plexus block and postoperative TENS applied.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-15 score	Postoperative 24th hour	Minimum value: 0, Maximum value: 150, higher scores mean better.

Secondary Outcome Measures

Name	Time	Method
Incidence of rebound pain	24 hours after surgery	Rebound pain is described as severe pain (NRS ≥ 7)
Opioid consumption	48 hours	Opioid consumption
The difference of pain score before and after interscalene block resolution	First 24 hours after interscalene block effect disappears	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.
Number of Participants with Surgical infection	Postoperative 14 days	Number of Participants diagnosed with surgical infection
Quality of Recovery-15 score	postoperative day 2 and 7	Minimum value: 0, Maximum value: 150, higher scores mean better.
Numerical Rating Scale	48 hours	Range 0-10, 0=no pain, 10=the worse pain ever.
Sleep Quality measured with Likert Scale	One week after surgery	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.

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey