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

• ClinicalTrials.gov Identifier: NCT05962853
• Recruitment Status: Recruiting
• First Posted: July 27, 2023
• Last Update Posted: July 27, 2023
• Sponsor: Cukurova University
• Information provided by (Responsible Party): Cansel Bozer, Cukurova University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cholecystitis; Gallstone; Cholecystolithiasis	Other: Experimental group (Transcutaneous Electrical Nerve Stimulation)	Not Applicable

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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Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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

• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Application will be made by the researcher and the outcome will be assessements will be performed by a investigator who is blinded to group allocation
• Primary Purpose: Treatment
• Official Title: Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study
• Actual Study Start Date: June 15, 2023
• Estimated Primary Completion Date: June 15, 2024
• Estimated Study Completion Date: June 15, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Experimental group (Transcutaneous Electrical Nerve Stimulation); The application will be applied at 8 hour intervals in the first 24 hours after the surgery.
No Intervention: Control Group ( TENS will not be applied ); Application of the control group: TENS will not be applied to this group.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. APS-POQ-R - American Pain Society Patient Outcome [ Time Frame: 24 hours ]
   American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Cansel Bozer; +905434332624; cansel9815@gmail.com

Contact: Ceylan Kişial; +905068010561; cylnksl@gmail.com

Locations

Turkey

Adana City Training and Research Hospital; Recruiting

Adana, Yüreğir / Adana, Turkey, 01220

Contact: Cansel Bozer

Sponsors and Collaborators

Cukurova University

Investigators

• Principal Investigator: Cansel Bozer; Cukurova University

More Information

• Responsible Party: Cansel Bozer, doctorate student, Cukurova University
• ClinicalTrials.gov Identifier: NCT05962853
• Other Study ID Numbers: CU-SBF-CB-02
• First Posted: July 27, 2023
• Last Update Posted: July 27, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cansel Bozer, Cukurova University:

Pain; Cholecystectomy; Nurse; TENS

Additional relevant MeSH terms:

Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Calculi; Pathological Conditions, Anatomical