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NCT Number: NCT06999200

Neural Therapy in Cesareans

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.

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual analogue scale

    Time frame: 48 hours

    1=no pain, 10=worst pain

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

905054525261

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Evaluation of the Effectiveness of Subcutaneous and Intracutaneous Local Anesthesia for Postoperative Analgesia in Patients Undergoing Cesarean Section Under General Anesthesia: a Prospective Randomized Controlled Trial (RCT)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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