Acute Pain ManagementNCT06939725
Transverse Abdominis Plane (TAP) Block Versus Transversalis Fascia Plane Block (TFPB) After Cesarean Delivery
An observational study of Acute Pain Management and Caesarean Section, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Pain Management, Caesarean Section
- What is being tested?
- Transversus abdominis plane (TAP) block and Transversalis Fascia Plane Block
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 31 Mar 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants who underwent elective cesarean section and received regional anesthesia for postoperative analgesia
Who may be able to join
- >18 years
- Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia
Who cannot join
- <18 years
- Emergency surgery
- BMI > 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
- Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10^3/mm^3 or INR > 1.5)
- Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
- Other relevant maternal or neonatal clinical conditions requiring treatment and at the discretion of the investigators, such as gestational hypertension, impaired renal or hepatic function, postpartum hemorrhage
- Chronic pain conditions and concomitant use of analgesics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Training and Research Hospital
Samsun, İ̇lkadim, 55000
About this study
Official title: Outcomes of Postoperative Analgesia Protocols and Their Impact on Recovery Quality in Patients Undergoing Cesarean Section
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
Read the detailed description
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). In this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery. The aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
- Conditions
- Acute Pain Management, Caesarean Section
- Being tested
- Transversus abdominis plane (TAP) block, Transversalis Fascia Plane Block
- Keywords
- ObsQoR-10, Transversalis fascia plane block, Caesarean Section, Transverse abdominis plane block, numeric rating scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) blockOther
We apply different nerve blocks to patients for pain relief after cesarean surgery. Transversus abdominis plane block was applied to this group
Transversalis Fascia Plane BlockOther
We apply different nerve blocks to patients for pain relief after cesarean surgery. Transversalis Fascia Plane Block was applied to this group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Transversus abdominis plane block was performed immediately after cesarean section. Receives: Other: Transversus abdominis plane (TAP) block | |
| Group 2 | Transversalis fascial plane block was performed immediately after cesarean section Receives: Other: Transversalis Fascia Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: postoperative 24 hours
Secondary outcomes (1)
ObsQoR-10
The ObsQoR-10 questionnaire consists of 10 questions that assess the patient-reported quality of recovery in obstetric patients' postoperative period using an 11-point Likert scale (0 = strongly negative; 10 = strongly positive) that points to a minimum score of 0 (worst possible recovery) and a maximum score of 100 (best possible recovery)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain ManagementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEVDA AKDENIZ, Assoc Prof, Principal investigator, Samsun UniversityHATİCE SELÇUK KUŞDERCİ, Asst. Prof., Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939725
- Sponsor's protocol ID
- GOKAEK 2024/22/14
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Postoperative Analgesia Protocols and Their Impact on Recovery Quality in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT06939725
- Acronym / sponsor ID
- GOKAEK 2024/22/14
- Conditions
- Acute Pain Management, Caesarean Section
- Keywords
- ObsQoR-10, Transversalis fascia plane block, Caesarean Section, Transverse abdominis plane block, numeric rating scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Apr 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.
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
Detailed description
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). In this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery. The aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Transversus abdominis plane (TAP) blockTransversus abdominis plane block was performed immediately after cesarean section. |
| Group 2 | – | Other: Transversalis Fascia Plane BlockTransversalis fascial plane block was performed immediately after cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent elective cesarean section and received regional anesthesia for postoperative analgesia
Key inclusion criteria (2 listed)
- >18 years
- Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia
Key exclusion criteria (7 listed)
- <18 years
- Emergency surgery
- BMI > 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
- Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10^3/mm^3 or INR > 1.5)
- Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
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 |
|---|---|---|
| Transversus abdominis plane (TAP) blockWe apply different nerve blocks to patients for pain relief after cesarean surgery. Transversus abdominis plane block was applied to this group | Other | Group 1 |
| Transversalis Fascia Plane BlockWe apply different nerve blocks to patients for pain relief after cesarean surgery. Transversalis Fascia Plane Block was applied to this group | Other | Group 2 |
Primary outcome
Postoperative pain
Time frame: postoperative 24 hours
Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
1 secondary outcome
ObsQoR-10
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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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.
SEVDA AKDENIZ, Assoc Prof principal investigator
Samsun University
HATİCE SELÇUK KUŞDERCİ, Asst. Prof. study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain Management and Caesarean Section, run by Samsun 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 2 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: finished, as of the sponsor's last update on 30 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain (time frame: postoperative 24 hours). 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 30 Apr 2025.