Skip to main content
Clinical Trials/NCT05962853
NCT05962853
Completed
Not Applicable

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

Cukurova University1 site in 1 country140 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystitis; Gallstone
Sponsor
Cukurova University
Enrollment
140
Locations
1
Primary Endpoint
The Numerical Rating Scale (NRS)
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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

Detailed Description

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. .

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
June 15, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cansel Bozer

specialist nurse

Cukurova University

Eligibility Criteria

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,

Exclusion Criteria

  • refuse to participate in the study

Outcomes

Primary Outcomes

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

  • American Pain Society Patient Outcome(24 hours)

Study Sites (1)

Loading locations...

Similar Trials