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Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

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ClinicalTrials.gov Identifier: NCT02642796
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
MENEKSE OKSAR, Mustafa Kemal University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Hip Fracture Device: transcutaneous electric nerve stimulation Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Two Different Transcutaneous Electrical Nerve Stimulation Application Sites in Reducing Postoperative Pain After Hip Fracture Surgery
Actual Study Start Date : March 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group I (control)
Patient controlled analgesia (epidural fentanyl): PCA only
Experimental: group II
PCA plus lumbar plexus & sciatic nerve transcutaneous electric nerve stimulation (LS-TENS)
Device: 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.

Other Name: Intelect portable TENS

Experimental: group III
PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS)
Device: 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.

Other Name: Intelect portable TENS




Primary Outcome Measures :
  1. Visual analog scale for pain [ Time Frame: 48 h postoperatively ]
    Postoperative pain intensity is assessed using VAS for pain postoperatively.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642796


Contacts
Contact: Menekse Oksar, M.D. +3262291000 ext 3062 menekseoksar@mku.edu.tr

Locations
Turkey
Mustafa Kemal University Hospital Recruiting
Hatay, Turkey, 31100
Contact: Menekse G Oksar, MD    +3262992900 ext 3062    menekseoksar@mku.edu.tr   
Principal Investigator: Menekse Oksar, MD         
Sub-Investigator: Selim Turhanoglu, MD         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
Principal Investigator: Menekse Oksar, M.D. Mustafa Kemal University Medical School

Additional Information:
Publications of Results:
Responsible Party: MENEKSE OKSAR, Assistant Professor, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT02642796     History of Changes
Other Study ID Numbers: 2013/34
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MENEKSE OKSAR, Mustafa Kemal University:
Percutaneous Electric Nerve Stimulation
Lumbosacral plexus
surgical wound
postoperative analgesia
transcutaneous electrical stimulation

Additional relevant MeSH terms:
Hip Fractures
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries