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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia Postoperative Pain Quality of Life Transcutaneous Electric Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active TENS group

Conventional transcutaneous electric nerve stimulation

Group Type ACTIVE_COMPARATOR

Transcutaneous electric nerve stimulation

Intervention Type DEVICE

Conventional transcutaneous electric nerve stimulation

Placebo TENS group

0 amperes transcutaneous electric nerve stimulation

Group Type PLACEBO_COMPARATOR

Transcutaneous electric nerve stimulation

Intervention Type DEVICE

Conventional transcutaneous electric nerve stimulation

Interventions

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Transcutaneous electric nerve stimulation

Conventional transcutaneous electric nerve stimulation

Intervention Type DEVICE

Other Intervention Names

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TENS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No