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Completed

NCT Number: NCT02642796

Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

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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Key information

Conditions

Postoperative Pain Femoral Fractures Fractures, Bone Hip Fracture Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustafa Kemal University Hospital

Hatay, 31100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous electric nerve stimulation

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.

Other names: Intelect portable TENS

Primary outcomes

  1. Visual analog scale for pain

    Time frame: 48 h postoperatively

    Postoperative pain intensity is assessed using VAS for pain postoperatively.

Secondary outcomes

  1. Ramsey sedation scores

    Time frame: 48 h postoperatively

    Sedation score is assessed for safety of epidural analgesic use.

  2. Frequencies of PCA demand

    Time frame: 48 h postoperatively

    Patient demand will be assessed by PCA demand

  3. PCA delivery counts

    Time frame: 48 h postoperatively

    Delivery count shows the actual PCA delivery. It is different from the demand.

  4. Total fentanyl consumption

    Time frame: 48 h postoperatively

    Total analgesic use during the study period

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2015
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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