Postoperative PainNCT06221280
Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression
A study testing Nerve block in people with Postoperative Pain and Cesarean Section, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Cesarean Section, Postpartum Depression
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a good mental status,
- Those aged ≥18 years,
- Term pregnant (gestational age ≥ 36 weeks),
- American Society of Anesthesiologists class II-III,
- Patients who underwent cesarean section with spinal anesthesia will be included.
Who cannot join
- Having labor at term or obstetric emergency,
- Having a twin pregnancy,
- Having a diagnosed psychiatric disorder/using psychiatric medication,
- Those who are allergic to local anesthetics and/or drugs used in the study,
- The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
- Having peripheral neuropathy or neuromuscular disease,
- Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
KahramanmarasSIU
Kahramanmaraş, Kahramanmaraş, 46100
About this study
Official title: Effects of Transversus Abdominis and Erector Spina Plane Blocks on Post-Cesarean Pain Control and Postpartum Depression
At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.
- Conditions
- Postoperative Pain, Cesarean Section, Postpartum Depression
- Being tested
- Nerve block
- Keywords
- Nerve block, cesarean, postpartum depression
- Medical subject headings
- Pain, Postoperative, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Group E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector.
Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Patients who underwent erector spinae plane block Receives: Procedure: Nerve block |
| Group T | Active comparator | Patients who underwent transversus abdominis plane block Receives: Procedure: Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS score)
Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section
Measured: 12 months
Secondary outcomes (1)
Postpartum depression (Edinnburg Depression Scale)
Comparison of the effectiveness of blocks for analgesia in terms of postpartum depression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2023
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Calisir, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221280
- Sponsor's protocol ID
- 2023/10-02
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transversus Abdominis and Erector Spina Plane Blocks on Post-Cesarean Pain Control and Postpartum Depression
- ClinicalTrials.gov ID
- NCT06221280
- Acronym / sponsor ID
- 2023/10-02
- Conditions
- Postoperative Pain, Cesarean Section, Postpartum Depression
- Keywords
- Nerve block, cesarean, postpartum depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Jan 2024 (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.
At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Procedure: Nerve blockPatients who underwent erector spinae plane block |
| Group T | Active comparator | Procedure: Nerve blockPatients who underwent transversus abdominis plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a good mental status,
- Those aged ≥18 years,
- Term pregnant (gestational age ≥ 36 weeks),
- American Society of Anesthesiologists class II-III,
- Patients who underwent cesarean section with spinal anesthesia will be included.
Key exclusion criteria (7 listed)
- Having labor at term or obstetric emergency,
- Having a twin pregnancy,
- Having a diagnosed psychiatric disorder/using psychiatric medication,
- Those who are allergic to local anesthetics and/or drugs used in the study,
- The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
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 |
|---|---|---|
| Nerve blockGroup E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector. Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia. | Procedure or surgery | Group E, Group T |
Primary outcome
Pain (VAS score)
Time frame: 12 months
Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section
1 secondary outcome
Postpartum depression (Edinnburg Depression Scale)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Postoperative Pain and Cesarean Section, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS score) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.