Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study

Cholecystolithiasis Clinical Trial

— TENS  

Official title:

Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962853
• Other study ID #: CU-SBF-CB-02
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2023
• Source: Cukurova University
• Contact: Cansel Bozer
• Phone: +905434332624
• Email: cansel9815[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis; Gallstone
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Other:
• Experimental group (Transcutaneous Electrical Nerve Stimulation)
The application will be applied at 8 hour intervals in the first 24 hours after the surgery.

Locations

Country	Name	City	State
Turkey	Adana City Training and Research Hospital	Adana	Yüregir / Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Numerical Rating Scale (NRS)	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.	24 hours
Secondary	APS-POQ-R - American Pain Society Patient Outcome	American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.	24 hours