Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Not Applicable

Completed

• Conditions: Postoperative Pain; Hip Fracture
• Interventions: Device: transcutaneous electric nerve stimulation

• Registration Number: NCT02642796
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-12-25
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group II	transcutaneous electric nerve stimulation	PCA plus lumbar plexus \& sciatic nerve transcutaneous electric nerve stimulation (LS-TENS)
group III	transcutaneous electric nerve stimulation	PCA plus surgical wound transcutaneous electric nerve stimulation ( SW-TENS)

Primary Outcome Measures

Name	Time	Method
Visual analog scale for pain	48 h postoperatively	Postoperative pain intensity is assessed using VAS for pain postoperatively.

Secondary Outcome Measures

Name	Time	Method
Frequencies of PCA demand	48 h postoperatively	Patient demand will be assessed by PCA demand
Ramsey sedation scores	48 h postoperatively	Sedation score is assessed for safety of epidural analgesic use.
Total fentanyl consumption	48 h postoperatively	Total analgesic use during the study period
PCA delivery counts	48 h postoperatively	Delivery count shows the actual PCA delivery. It is different from the demand.

Trial Locations

Locations (1)

Mustafa Kemal University Hospital; 🇹🇷 Hatay, Turkey