Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair (TENS1)

Lithuanian University of Health Sciences

Status: Completed

Conditions: Postoperative Pain; Quality of Life; Inguinal Hernia; Transcutaneous Electric Nerve Stimulation

Treatments: Device: Transcutaneous electric nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03739060

TENS1

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Active TENS group

Active Comparator group

Description:

Conventional transcutaneous electric nerve stimulation

Treatment:

Device: Transcutaneous electric nerve stimulation

Placebo TENS group

Placebo Comparator group

Description:

0 amperes transcutaneous electric nerve stimulation

Treatment:

Device: Transcutaneous electric nerve stimulation