Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy

NCT ID: NCT05962853

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-06-15

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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Conditions

Cholecystitis; Gallstone; Cholecystolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group ( TENS will be applied )

After 30 minutes of TENS application 2 hours after the surgery, 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). TENS application hours will be arranged according to the patient in order to protect sleep integrity.

Group Type: EXPERIMENTAL

Experimental group (Transcutaneous Electrical Nerve Stimulation)

Intervention Type: OTHER

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

Control Group ( TENS will not be applied )

Application of the control group: TENS will not be applied to this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group (Transcutaneous Electrical Nerve Stimulation)

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Cansel Bozer

specialist nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cansel Bozer

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Adana City Training and Research Hospital

Adana, Yüreğir / Adana, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CU-SBF-CB-02

Identifier Type: -

Identifier Source: org_study_id