Clinical trial NCT03739060: Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair
Official title: Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Postoperative Pain
Quality of Life
Transcutaneous Electric Nerve Stimulation
Keywords: Inguinal hernia
Transcutaneous electric nerve stimulation
Postoperative pain
Quality of life
Pain threshold
Algometry
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Elective Lichtenstein repair for primary hernia
* Male gender
* No TENS procedures in the past
* American Society of Anesthesiologists physical status I or II
* No cognitive, speaking, hearing or visual disturbances
* No movement disorders

Exclusion Criteria:

* Non Lithuanian speaker
* Known allergy to a patch glue
* Chronic use of non-steroidal anti inflammatory drugs or opioids
* Neuropathic diseases
* General contraindication for TENS procedures (such as skin disorders in site of electrodes application or pacemaker)
* Not able to complete the questionnaires

Primary outcomes:
measure: Change in pain level as assessed by the VAS.
timeFrame: 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Secondary outcomes:
measure: Change in pressure pain threshold.
timeFrame: 1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
measure: Change in pressure pain tolerance.
timeFrame: 1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
measure: Change in hernia specific quality of life.
timeFrame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
measure: Change in overall quality of life.
timeFrame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
measure: Consumption of analgesic drugs.
timeFrame: 2 days postoperative
measure: Depression status influence to TENS effectiveness.
timeFrame: 2 days postoperative
measure: Anxiety status influence to TENS effectiveness.
timeFrame: 2 days postoperative
measure: Pain catastrophizing influence to TENS effectiveness.
timeFrame: 2 days postoperative
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Audrius Paršeliūnas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parseliunas A, Paskauskas S, Kubiliute E, Vaitekunas J, Venskutonis D. Transcutaneous Electric Nerve Stimulation Reduces Acute Postoperative Pain and Analgesic Use After Open Inguinal Hernia Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2021 May;22(5):533-544. doi: 10.1016/j.jpain.2020.11.006. Epub 2020 Dec 10.