Visual Analogue ScaleNCT06999200
Neural Therapy in Cesareans
An observational study of Visual Analogue Scale, run by Haseki Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Visual Analogue Scale
- What is being tested?
- neural therapy
- Type of treatment
- Injection or infusion
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 10 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 19-45 who underwent a caesarean section under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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
- Being tested
- neural therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous local anesthesia group | who received subcutaneous local anesthesia at the end of C/S surgery Receives: Drug: neural therapy | |
| Intracutaneous local anesthesia group | who received intracutaneous local anesthesia at the end of C/S surgery Receives: Drug: neural therapy | |
| Parenteral analgesia group | who received parenteral analgesia after C/S surgery Receives: Drug: neural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
1=no pain, 10=worst pain
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visual Analogue ScaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yilmaz Guler, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999200
- Sponsor's protocol ID
- NT-2016
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34014182Roofthooft 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.
PubMed 33370462
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06999200
- Acronym / sponsor ID
- NT-2016
- Conditions
- Visual Analogue Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous local anesthesia group | – | Drug: neural therapywho received subcutaneous local anesthesia at the end of C/S surgery |
| Intracutaneous local anesthesia group | – | Drug: neural therapywho received intracutaneous local anesthesia at the end of C/S surgery |
| Parenteral analgesia group | – | Drug: neural therapywho received parenteral analgesia after C/S surgery |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 19-45 who underwent a caesarean section under general anesthesia
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neural therapyThis 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. | Drug | Intracutaneous local anesthesia group, Parenteral analgesia group, Subcutaneous local anesthesia group |
Primary outcome
Visual analogue scale
Time frame: 48 hours
1=no pain, 10=worst pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Results publication: PubMed 34014182Reed 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.
- Results publication: PubMed 33370462Roofthooft 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Analogue Scale, run by Haseki Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emine yılmaz güler (905054525261, dr.emine.yilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999200, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.