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

Quality of Life Clinical Trial

— TENS1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739060
• Other study ID #: TENS1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 8, 2020

Study information

• Verified date: February 2021
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 8, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain
• Quality of Life
• Transcutaneous Electric Nerve Stimulation

Intervention

Device:
• Transcutaneous electric nerve stimulation
Conventional transcutaneous electric nerve stimulation

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.
Secondary	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.	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.
Secondary	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.	1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Secondary	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).	1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Secondary	Consumption of analgesic drugs.	The total amount of drugs, used for pain relief in hospital.	2 days postoperative
Secondary	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.	2 days postoperative
Secondary	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.	2 days postoperative
Secondary	Pain catastrophizing influence to TENS effectiveness.	Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.	2 days postoperative