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Completed

NCT Number: NCT03739060

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

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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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Quality of Life Signs and Symptoms Transcutaneous Electric Nerve Stimulation

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, LT44307, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electric nerve stimulation

Device

Conventional transcutaneous electric nerve stimulation

Other names: TENS

Primary outcomes

  1. Change in pain level as assessed by the VAS.

    Time frame: 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.

    Pain is assessed using a 100 mm handheld slide rule-type visual analogue scale (VAS) with values from 0 to 100 (0 = no pain, 100 = extreme pain) during lying, waking and getting out of bed. Total scores are averaged.

Secondary outcomes

  1. Change in pressure pain threshold.

    Time frame: 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.

    Pressure pain threshold assessed using digital pressure algometer examination in inguinal region (hernia and contralateral side). Pressure in newtons (N) that evokes minimal sensation of pain is assessed.

  2. Change in pressure pain tolerance.

    Time frame: 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.

    Pressure pain tolerance assessed using digital pressure algometer examination in inguinal region (hernia and contralateral side). Pressure in newtons (N) that evokes maximal tolerable sensation of pain is assessed.

  3. Change in hernia specific quality of life.

    Time frame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.

    Hernia specific quality of life is assessed using self reported questionnaire Carolina's comfort scale (CCS) application, providing a 0 to 115 score.

  4. Change in overall quality of life.

    Time frame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.

    Overall quality of life is assessed using self reported short form (36) health survey questionnaire (SF-36) application.The SF-36 consists of 36 items, that aggregate into 8 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored on a value of 0 (poor health) to 100 (best health).

  5. Consumption of analgesic drugs.

    Time frame: 2 days postoperative

    The total amount of drugs, used for pain relief in hospital.

  6. Depression status influence to TENS effectiveness.

    Time frame: 2 days postoperative

    Depression status is assessed using preoperative completed patient health questionnaire- 9 (PHQ-9), providing a 0 to 27 severity score.

  7. Anxiety status influence to TENS effectiveness.

    Time frame: 2 days postoperative

    Anxiety status is assessed using preoperative completed generalized anxiety disorder scale -7 (GAD-7), providing a 0 to 21 severity score.

  8. Pain catastrophizing influence to TENS effectiveness.

    Time frame: 2 days postoperative

    Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair

Acronym: TENS1

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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