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

NCT03761862 | Completed

• 1 other identifier: Neuraltherapyinbtl
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain, Postoperative; Neural Therapy of Huneke; Dysmenorrhea; Dyspareunia; Sterilization, Tubal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

The control group with bilateral tubal ligation

Procedure: Neural Therapy

Neural Therapy

The treatment group

Procedure: Neural Therapy

Interventions

Neural Therapy PROCEDURE

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.

Control; Neural Therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who undergo bilateral tubal ligation

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Dysmenorrhea; Dyspareunia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-11