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NCT03072888 Clinical Trial

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy

Pain, Acute Clinical Trial

Official title:
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03072888
Other study ID # TENS
Secondary ID
Status Completed
Phase N/A
First received February 20, 2017
Last updated May 5, 2017
Start date March 31, 2016
Est. completion date May 5, 2017

Study information
Verified date May 2017
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.

Description:

The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 5, 2017
Est. primary completion date May 5, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients aged between18-65 undergoing elective abdominal hysterectomy

- ASA (American Society of Anesthesiologist) I,II physical status

Exclusion Criteria:

- Not agreement with the study,Dermatological lesion affecting the electrode place,

- Chronic or preprocedural use of opioids, steroids or psychoactive drugs,

- Allergy to drugs used during trials,

- Previous experience in TENS,

- Kidney, liver, neurological or cardiovascular system disease

- Body mass index>40

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TENS
Transcutaneous Electrical Nerve Stimulation will be apply

Locations
Country Name City State
Turkey Gaziosmanpasa University Medical School Tokat

Sponsors (1)
Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Adverse events The number of adverse events will be recorded During 24 hours after surgery
Primary Quality of Recovery QoR-40 (Quality of Recovery 40) form will be used for evaluation At twenty-four hours after surgery
Secondary Pain Dynamic and static pain will be evaluated by visual analog scale(VAS) During 24 hours after surgery
Secondary Analgesic Consumption Total consumption of analgesic will be recorded During 24 hours after surgery
Secondary Postoperative Nausea and Vomiting Nausea and Vomiting scores will be recorded During 24 hours after surgery
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