Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642796
• Other study ID #: 2013/34
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University Hospital	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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 201 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale for pain	Postoperative pain intensity is assessed using VAS for pain postoperatively.	48 h postoperatively
Secondary	Ramsey sedation scores	Sedation score is assessed for safety of epidural analgesic use.	48 h postoperatively
Secondary	Frequencies of PCA demand	Patient demand will be assessed by PCA demand	48 h postoperatively
Secondary	PCA delivery counts	Delivery count shows the actual PCA delivery. It is different from the demand.	48 h postoperatively
Secondary	Total fentanyl consumption	Total analgesic use during the study period	48 h postoperatively

External Links

•   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..
•   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.