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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS group | Active Comparator | Conventional transcutaneous electric nerve stimulation |
|
| Placebo TENS group | Placebo Comparator | 0 amperes transcutaneous electric nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electric nerve stimulation | Device | Conventional transcutaneous electric nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrius Paršeliūnas, MD | Lithuanian University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | LT44307 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33309784 | Derived | 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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. |
| 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. |
| 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. |
| Consumption of analgesic drugs. | The total amount of drugs, used for pain relief in hospital. | 2 days postoperative |
| 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 |
| 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 |
| 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 |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |