Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Study Overview
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Brief Summary
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Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.

Detailed Description
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The patients underwent undergo fractured hip surgery will be distributed into three groups with respect to the mode of postoperative analgesia applied: Group I (control): PCA only; group II: PCA plus lumbar plexus & sciatic nerve TENS (LS-TENS); group III: PCA plus surgical wound TENS (SW-TENS). TENS will be applied every 2 hours for 30-40 minutes during 48 hours postoperatively. Visual analogue score (VAS), Ramsey sedation scores, frequencies of PCA demand and counts of PCA delivery, as well as total analgesic consumption will be noted and compared between groups at various time intervals. Visual analog scale (VAS) will be applied at 2 months postoperatively VAS and Mcgill pain questionnaire will be applied at the 6th and 24th months of the surgery to assess acute and chronic pain in the study population and the differences among groups.

Official Title
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Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery

Conditions
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Postoperative Pain, Hip Fracture

Intervention / Treatment
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* Device: transcutaneous electric nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients will be scheduled for surgery due to hip fracture in Mustafa Kemal University Hospital will be included in the study. Exclusion Criteria: Patients with a history of opioid analgesic abuse, or sensitivity to opioids, and those with clinically significant systemic (cardiovascular, pulmonary, hepatic, renal, neurologic etc.) diseases, will be excluded.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group I (control)<br>Patient controlled analgesia (epidural fentanyl): PCA only | |
| Experimental: group II<br>PCA plus lumbar plexus & sciatic nerve transcutaneous electric nerve stimulation (LS-TENS) | Device: transcutaneous electric nerve stimulation<br>* The TENS device will be applied for treatment periods of 30-40 minutes. The electrodes will be connected to the TENS device are stimulated in modulation mode and the parameters will be adjusted as pulse width of 60 μs,frequency of 120 Hz and the stimulation intensity as high as the subject could tolerate. Electrodes will be placed on either lumbar and sciatic nerve tracing unilaterally or on either side or parallel to the surgical wound.<br>* Other names: Intelect portable TENS;|
| Experimental: group III<br>PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS) | Device: transcutaneous electric nerve stimulation<br>* The TENS device will be applied for treatment periods of 30-40 minutes. The electrodes will be connected to the TENS device are stimulated in modulation mode and the parameters will be adjusted as pulse width of 60 μs,frequency of 120 Hz and the stimulation intensity as high as the subject could tolerate. Electrodes will be placed on either lumbar and sciatic nerve tracing unilaterally or on either side or parallel to the surgical wound.<br>* Other names: Intelect portable TENS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for pain | Postoperative pain intensity is assessed using VAS for pain postoperatively. | 48 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ramsey sedation scores | Sedation score is assessed for safety of epidural analgesic use. | 48 h postoperatively | 
| Frequencies of PCA demand | Patient demand will be assessed by PCA demand | 48 h postoperatively | 
| PCA delivery counts | Delivery count shows the actual PCA delivery. It is different from the demand. | 48 h postoperatively | 
| Total fentanyl consumption | Total analgesic use during the study period | 48 h postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Electric Nerve Stimulation, Lumbosacral plexus, surgical wound, postoperative analgesia, transcutaneous electrical stimulation