Clinical trial NCT05962853: Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy
Official title: Effect of Trans Electrical Nerve Stimulation on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis; Gallstone
Cholecystolithiasis
Keywords: Pain
Cholecystectomy
Nurse
TENS
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient.

Application of the control group: TENS will not be applied to this group
Primary purpose: TREATMENT

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.

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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,
* 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

Primary outcomes:
measure: The Numerical Rating Scale (NRS)
timeFrame: 24 hours
Secondary outcomes:
measure: American Pain Society Patient Outcome
timeFrame: 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
state: Yüreğir / Adana
Study officials:
affiliation: Cukurova University
name: Cansel Bozer
role: PRINCIPAL_INVESTIGATOR
References: