Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hip Fracture
• Intervention / Treatment: Device: transcutaneous electric nerve stimulation

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Hatay, Turkey, 31100
    • Mustafa Kemal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Intelect portable TENS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mustafa Kemal University
• Investigators: Principal Investigator: Menekse Oksar, M.D., Mustafa Kemal University Medical School

Publications and helpful links

General Publications

• Hamza MA, White PF, Ahmed HE, Ghoname EA. Effect of the frequency of transcutaneous electrical nerve stimulation on the postoperative opioid analgesic requirement and recovery profile. Anesthesiology. 1999 Nov;91(5):1232-8. doi: 10.1097/00000542-199911000-00012.
• Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
• Lan F, Ma YH, Xue JX, Wang TL, Ma DQ. Transcutaneous electrical nerve stimulation on acupoints reduces fentanyl requirement for postoperative pain relief after total hip arthroplasty in elderly patients. Minerva Anestesiol. 2012 Aug;78(8):887-95. Epub 2012 Apr 24.

Helpful Links

• Use of TENS at mixed (2- and 100-Hz) frequencies of stimulation produced a slightly greater opioid-sparing effect than either low (2-Hz) or high (100 Hz) frequencies alone.
• High-TAES (9-12 mA) produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery.
• TENS on specific acupoints is an effective and complementary approach to reduce postoperative analgesic requirement in elderly patients after total hip arthroplasty..

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 25, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: postoperative analgesia; transcutaneous electrical stimulation; surgical wound; Percutaneous Electric Nerve Stimulation; Lumbosacral plexus
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Hip Fractures
• Other Study ID Numbers: 2013/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No