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Neural Therapy in Cesareans

NCT ID: NCT06999200

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Visual Analogue Scale

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Subcutaneous local anesthesia group

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

neural therapy

Intervention Type 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

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

neural therapy

Intervention Type 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.

Parenteral analgesia group

who received parenteral analgesia after C/S surgery

neural therapy

Intervention Type 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.

Interventions

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neural therapy

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emine Yilmaz Guler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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emine yılmaz güler

Role: CONTACT

Phone: 905054525261

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 34014182 (View on PubMed)

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.

Reference Type RESULT
PMID: 33370462 (View on PubMed)

Other Identifiers

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NT-2016

Identifier Type: -

Identifier Source: org_study_id