Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation

Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients

The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Dysmenorrhea; Dyspareunia; Sterilization, Tubal; Neural Therapy of Huneke
• Intervention / Treatment: Procedure: Neural Therapy

• Study Type: Observational
• Enrollment (Actual): 113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo bilateral tubal ligation admitted to the training and research hospital.

Description

Inclusion Criteria:

• Patients who undergo bilateral tubal ligation

Exclusion Criteria:

• Previous abdominal surgery
• Patients with diseases that could have neurologic complications (DM, SLE ...)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; The control group with bilateral tubal ligation	Procedure: Neural Therapy; Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.
Neural Therapy; The treatment group	Procedure: Neural Therapy; Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe pain.	1 year later

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Menstruation Disturbances; Pelvic Pain; Pain, Postoperative; Dysmenorrhea; Dyspareunia
• Other Study ID Numbers: Neuraltherapyinbtl

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No