Clinical trial NCT05833113: Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery
Official title: Effects of Transcutaneous Electrical Nerve Stimulation for Postoperative Quality of Recovery After Shoulder Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Recovery
Keywords: Interscalene brachial plexus block
Transcutaneous electrical nerve stimulation
Rebound pain
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Recovery-15 score
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Quality of Recovery-15 score
timeFrame: postoperative day 2 and 7
measure: Numerical Rating Scale
timeFrame: 48 hours
measure: Opioid consumption
timeFrame: 48 hours
measure: The difference of pain score before and after interscalene block resolution
timeFrame: First 24 hours after interscalene block effect disappears
measure: Incidence of rebound pain
timeFrame: 24 hours after surgery
measure: Sleep Quality measured with Likert Scale
timeFrame: One week after surgery
measure: Number of Participants with Surgical infection
timeFrame: Postoperative 14 days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
References: