Neural Therapy in Cesareans

NCT06999200 | Not Yet Recruiting

• 1 other identifier: NT-2016
• Study Type: observational
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the management of pain after Caesarean section (C/S), opioid or nonsteroidal anti-inflammatory parenteral drugs are applied. These drugs are insufficient in some cases and may cause pain attacks during the day. Higher doses and repeated drug applications or combined drug administration may cause drug side effects and interactions. Alternative applications to provide analgesia include subcutaneous and intracutaneous local anesthetic application to the wound site. Although the effectiveness of these applications has been tested in individuals with different clinical characteristics and has been shown to be largely more successful, they have not been sufficiently introduced into routine practice. There is a need to review the pain methods suggested in the literature and develop new solutions that can be applied more optimally, improve the patient's pain management in the postoperative period, and increase their quality of life and satisfaction. It aims to evaluate the success of subcutaneous and intracutaneous local anesthesia applications compared to traditional applications, and to find the most optimal management.

Conditions

Visual Analogue Scale

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  1=no pain, 10=worst pain

  48 hours

Study Arms (3)

Subcutaneous local anesthesia group

who received subcutaneous local anesthesia at the end of C/S surgery

Drug: neural therapy

Intracutaneous local anesthesia group

who received intracutaneous local anesthesia at the end of C/S surgery

Drug: neural therapy

Parenteral analgesia group

who received parenteral analgesia after C/S surgery

Drug: neural therapy

Interventions

neural therapy DRUG

This prospective study will be conducted with mothers who underwent general anesthesia for labor or elective cesarean delivery and local anesthesia for postoperative pain management during a one-year period following ethical approval.

Intracutaneous local anesthesia group; Parenteral analgesia group; Subcutaneous local anesthesia group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 19-45 who underwent a caesarean section under general anesthesia

You may qualify if:

• Healthy pregnancy,
• Term (\>37 weeks) and preterm (28-34 weeks) pregnancy,
• Cases that received general anesthesia for cesarean section,
• Cases with and without labor,
• Cases with and without obesity,
• Cases that had their first or second cesarean section

You may not qualify if:

• Pregnant women under 19 years of age,
• Those with a history of allergic reactions to analgesics to be used,
• Stillbirth,
• Surgical complications during C/S and placement of an abdominal drain,
• No head or breech presentation during C/S,
• Occiput posterior presentation during C/S,
• Anhydramnios and polyhydramnios,
• Allergic reactions to the drugs used in the study, alcohol dependence, drug and substance dependence, chronic pain syndrome, neuropathic pain disorder history,
• History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, psychiatric, metabolic disease.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Related Publications (2)

• Reed SE, Tan HS, Fuller ME, Krishnamoorthy V, Ohnuma T, Raghunathan K, Habib AS. Analgesia After Cesarean Delivery in the United States 2008-2018: A Retrospective Cohort Study. Anesth Analg. 2021 Dec 1;133(6):1550-1558. doi: 10.1213/ANE.0000000000005587.

  PMID: 34014182 RESULT

• Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.

  PMID: 33370462 RESULT

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

emine yılmaz güler

CONTACT

905054525261; dr.emine.yilmaz@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 31, 2025
• Study Start: June 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: October 10, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share