Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2021-09-01

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.

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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.

Conditions

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Postoperative Pain Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group I (control)

Patient controlled analgesia (epidural fentanyl): PCA only

Group Type NO_INTERVENTION

No interventions assigned to this group

group II

PCA plus lumbar plexus \& sciatic nerve transcutaneous electric nerve stimulation (LS-TENS)

Group Type EXPERIMENTAL

transcutaneous electric nerve stimulation

Intervention Type DEVICE

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.

group III

PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS)

Group Type EXPERIMENTAL

transcutaneous electric nerve stimulation

Intervention Type DEVICE

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.

Interventions

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transcutaneous electric nerve stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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Intelect portable TENS

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No