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

NCT03739060 | Completed

• 1 other identifier: TENS1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in pain level as assessed by the VAS.

  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.

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

Secondary Outcomes (8)

• Change in pressure pain threshold.

  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.

• Change in pressure pain tolerance.

  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.

• Change in hernia specific quality of life.

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

• Change in overall quality of life.

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

• Consumption of analgesic drugs.

  2 days postoperative

Study Arms (2)

Active TENS group

ACTIVE COMPARATOR

Conventional transcutaneous electric nerve stimulation

Device: Transcutaneous electric nerve stimulation

Placebo TENS group

PLACEBO COMPARATOR

0 amperes transcutaneous electric nerve stimulation

Device: Transcutaneous electric nerve stimulation

Interventions

Transcutaneous electric nerve stimulation DEVICE

Conventional transcutaneous electric nerve stimulation

Also known as: TENS

Active TENS group; Placebo TENS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT44307, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 33309784 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Audrius Paršeliūnas, MD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 13, 2018
• Study Start: August 1, 2018
• Primary Completion: February 8, 2020
• Study Completion: July 8, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

LI (1)