NCT03739060: TENS1

Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair

Completed NA Last updated 18 February 2021

What this trial tests

NA trial testing Transcutaneous electric nerve stimulation in Inguinal Hernia in 80 participants. Completed in 8 July 2020.

Timeline

1 August 2018

Primary endpoint
8 February 2020

8 July 2020

Quick facts

Lead sponsor	Lithuanian University of Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 August 2018
Primary completion	8 February 2020
Estimated completion	8 July 2020
Sites	1 location across Lithuania

Drugs / interventions tested

• Transcutaneous electric nerve stimulation

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →
• Postoperative Pain — all drugs for Postoperative Pain →
• Quality of Life — all drugs for Quality of Life →
• Transcutaneous Electric Nerve Stimulation — all drugs for Transcutaneous Electric Nerve Stimulation →

Sponsor

Lithuanian University of Health Sciences

Who can join

Adults 18 to 75, male only, with Inguinal Hernia or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. It is frequently associated with acute postoperative and chronic pain. Due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. However opioids have many side effects. Interventional treatment, such as transversus abdominis plain (TAP) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. The hypoalgesic effect of transcutaneous electric nerve stimulation (TENS) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. However it could be a promising part of multi-modal pain treatment for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on hernia specific quality of life (QoL) after Lichtenstein hernia repair.

Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.

Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late postoperative period.

Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.

Aim#4 To determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with TENS effectiveness.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcutaneous Electric Nerve Stimulation Reduces Acute Postoperative Pain and Analgesic Use After Open Inguinal Hernia Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.
   Parseliunas A, Paskauskas S, Kubiliute E, Vaitekunas J, et al · · 2021 · cited 20× · PMID 33309784 · DOI 10.1016/j.jpain.2020.11.006
2. Transcutaneous Electric Nerve Stimulation Reduces Pathological Sensation of Mesh One Week after Open Inguinal Hernia Surgery: Follow-Up Results from a Randomized, Double Blind and Placebo-Controlled Trial.
   Parseliunas A, Paskauskas S, Simatoniene V, Kubiliute E, et al · · 2022 · cited 3× · PMID 35743988 · DOI 10.3390/medicina58060725