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Completed

NCT Number: NCT05962853

Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy

The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve Stimulation) on patient outcomes after laparoscopic cholecystectomy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adana City Training and Research Hospital

Adana, Yüreğir / Adana, 01220, Turkey (Türkiye)

About this study

Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic cholecystectomy.

The most common complication after laparoscopic cholecystectomy is pain. Pain appears as incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal wall as a result of intra-abdominal intervention are seen. After laparoscopic cholecystectomy, the effect of general anesthesia and the proximity of the incision area to the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation, increased intra-abdominal pressure, stretching of the peritoneum, and consequently the tension in the muscle fibers in the diaphragm can cause pain.

Inability to control pain can lead to many undesirable conditions in the patient, such as reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This situation is also associated with increased hospital stay and financial burdens.In order to provide effective pain control, the combined use of pharmacological and non-pharmacological methods is important.Non-pharmacological methods are easy to learn, safe, have no definite contraindications, and provide pain management with non-drug applications. In a meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort and no serious side effects were observed.

Studies have shown that TENS application reduces postoperative pain level and analgesia consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be associated with a decrease in postoperative pain severity and complaints of nausea and vomiting. It is seen that there are not enough resources in the literature regarding the application of TENS after laparoscopic cholecystectomy.

The aim of this study is to evaluate the effect of TENS on patient outcomes after laparoscopic cholecystectomy.

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old,
  • Without pacemaker and arrhythmia,
  • No previous history of chronic pain, alcohol or drug addiction,
  • Not using TENS/opioids before surgery,
  • Epidural analgesia is not applied in the postoperative period, without cognitive impairment,
  • No thoracic incision other than cholecystectomy,
  • Having at least 1 drain
  • No metastatic disease
  • No need for mechanical ventilation
  • As a result of the evaluation by the physician, there is no objection to the application of TENS,
  • Who agree to participate in the study,
  • No postoperative complications
  • Patients with American Society of Anesthesiology (ASA) evaluation I, II, III will be included in the sample group.

Exclusion criteria

  • refuse to participate in the study

Treatment and study plan

Experimental group (Transcutaneous Electrical Nerve Stimulation)

Other

The application will be applied at 8 hour intervals in the first 24 hours after the surgery.

Primary outcomes

  1. The Numerical Rating Scale (NRS)

    Time frame: 24 hours

    The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.

Secondary outcomes

  1. American Pain Society Patient Outcome

    Time frame: 24 hours

    American Pain Society Patient Outcome (APS-POQ) Questionnaire-Revised to measure pain management and patient satisfaction developed. (APS-POQ) is a tool designed to evaluate patients' experiences and satisfaction with pain management. Developed by the American Pain Society, the questionnaire aims to assess patient-centered outcomes in acute pain management.

    The scoring system of the APS-POQ varies depending on the version used and the study's objectives. However, in general, the items in the questionnaire assess various aspects of pain's impact, and lower scores typically indicate better outcomes.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Effect of Trans Electrical Nerve Stimulation on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study

Acronym: TENS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Sep 12, 2025

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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