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

Primary Purpose

Inguinal Hernia, Postoperative Pain, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Transcutaneous electric nerve stimulation
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Transcutaneous electric nerve stimulation, Postoperative pain, Quality of life, Pain threshold, Algometry

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Lithuanian University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active TENS group

Placebo TENS group

Arm Description

Conventional transcutaneous electric nerve stimulation

0 amperes transcutaneous electric nerve stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in pressure pain threshold.
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.
Change in pressure pain tolerance.
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.
Change in hernia specific quality of life.
Hernia specific quality of life is assessed using self reported questionnaire Carolina's comfort scale (CCS) application, providing a 0 to 115 score.
Change in overall quality of life.
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).
Consumption of analgesic drugs.
The total amount of drugs, used for pain relief in hospital.
Depression status influence to TENS effectiveness.
Depression status is assessed using preoperative completed patient health questionnaire- 9 (PHQ-9), providing a 0 to 27 severity score.
Anxiety status influence to TENS effectiveness.
Anxiety status is assessed using preoperative completed generalized anxiety disorder scale -7 (GAD-7), providing a 0 to 21 severity score.
Pain catastrophizing influence to TENS effectiveness.
Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.

Full Information

First Posted
October 23, 2018
Last Updated
February 17, 2021
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03739060
Brief Title
Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair
Acronym
TENS1
Official Title
Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TENS group
Arm Type
Active Comparator
Arm Description
Conventional transcutaneous electric nerve stimulation
Arm Title
Placebo TENS group
Arm Type
Placebo Comparator
Arm Description
0 amperes transcutaneous electric nerve stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous electric nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
Conventional transcutaneous electric nerve stimulation
Primary Outcome Measure Information:
Title
Change in pain level as assessed by the VAS.
Description
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.
Time Frame
10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Secondary Outcome Measure Information:
Title
Change in pressure pain threshold.
Description
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.
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.
Title
Change in pressure pain tolerance.
Description
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.
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.
Title
Change in hernia specific quality of life.
Description
Hernia specific quality of life is assessed using self reported questionnaire Carolina's comfort scale (CCS) application, providing a 0 to 115 score.
Time Frame
1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Title
Change in overall quality of life.
Description
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).
Time Frame
1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Title
Consumption of analgesic drugs.
Description
The total amount of drugs, used for pain relief in hospital.
Time Frame
2 days postoperative
Title
Depression status influence to TENS effectiveness.
Description
Depression status is assessed using preoperative completed patient health questionnaire- 9 (PHQ-9), providing a 0 to 27 severity score.
Time Frame
2 days postoperative
Title
Anxiety status influence to TENS effectiveness.
Description
Anxiety status is assessed using preoperative completed generalized anxiety disorder scale -7 (GAD-7), providing a 0 to 21 severity score.
Time Frame
2 days postoperative
Title
Pain catastrophizing influence to TENS effectiveness.
Description
Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.
Time Frame
2 days postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrius Paršeliūnas, MD
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
LT44307
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
33309784
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.
Results Reference
derived

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

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