Pain, PostoperativeNCT05625009
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
A study testing Procedure/Surgery: Transversus Abdominis Plane Block (TAPB) and Procedure/Surgery: Erector Spinae Plane Block (ESPB) in people with Pain, Postoperative and Cesarean Section, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block
- What is being tested?
- Procedure/Surgery: Transversus Abdominis Plane Block (TAPB) and Procedure/Surgery: Erector Spinae Plane Block (ESPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2022to 2 Apr 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 45 years
- ASA2
- Undergoing cesarean section under spinal anesthesia
Who cannot join
- History of chronic pain
- Body mass index > 35
- Urgent/emergent surgeries
- Major bleeding
- Any additional surgical procedure
- Contraindication for any drugs used in the protocol
- The presence of any instrumentation in the procedure sites
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
Official title: Comparison of Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block in the Management of Postoperative Analgesia in Patients Who Had Cesarean Section Under Spinal Anesthesia
Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.
- Conditions
- Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block, Transversus Abdominis Plane Block
- Being tested
- Procedure/Surgery: Transversus Abdominis Plane Block (TAPB), Procedure/Surgery: Erector Spinae Plane Block (ESPB)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)Procedure or surgery
Patients received TAPB postoperatively
Procedure/Surgery: Erector Spinae Plane Block (ESPB)Procedure or surgery
Patients received ESPB postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Transversus Abdominis Plane Block (TAPB) | Experimental | patients received TAPB postoperatively Receives: Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB) |
| Experimental: Erector Spinae Plane Block (ESPB) | Experimental | patients received ESPB postoperatively Receives: Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients needed for rescue analgesic agent (diclofenac)
Measured: 24 hours
Secondary outcomes (3)
Percentage of patients needed for rescue analgesic agent (opioid)
Measured: 24 hours
the dose of the opioid used
Measured: 24 hours
Percentage of patients experienced chronic pain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start24 Nov 2022
- Primary completion24 Jan 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625009
- Sponsor's protocol ID
- 2021.10.227
- Status last verified
- May 2023
- First submitted
- 11 Nov 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block in the Management of Postoperative Analgesia in Patients Who Had Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05625009
- Acronym / sponsor ID
- 2021.10.227
- Conditions
- Pain, Postoperative, Cesarean Section, Erector Spinae Plane Block, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 22 Nov 2022 (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.
Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Transversus Abdominis Plane Block (TAPB) | Experimental | Procedure: Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)patients received TAPB postoperatively |
| Experimental: Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Procedure/Surgery: Erector Spinae Plane Block (ESPB)patients received ESPB postoperatively |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 - 45 years
- ASA2
- Undergoing cesarean section under spinal anesthesia
Key exclusion criteria (7 listed)
- History of chronic pain
- Body mass index > 35
- Urgent/emergent surgeries
- Major bleeding
- Any additional surgical procedure
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 |
|---|---|---|
| Procedure/Surgery: Transversus Abdominis Plane Block (TAPB)Patients received TAPB postoperatively | Procedure or surgery | Experimental: Transversus Abdominis Plane Block (TAPB) |
| Procedure/Surgery: Erector Spinae Plane Block (ESPB)Patients received ESPB postoperatively | Procedure or surgery | Experimental: Erector Spinae Plane Block (ESPB) |
Primary outcome
Percentage of patients needed for rescue analgesic agent (diclofenac)
Time frame: 24 hours
3 secondary outcomes
Percentage of patients needed for rescue analgesic agent (opioid)
Time frame: 24 hours
the dose of the opioid used
Time frame: 24 hours
Percentage of patients experienced chronic pain
Time frame: 2 months
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 6 May 2023.
- Individual participant dataSharing planned: Yes
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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 Procedure/Surgery: Transversus Abdominis Plane Block (TAPB) and Procedure/Surgery: Erector Spinae Plane Block (ESPB) in people with Pain, Postoperative and Cesarean Section, run by Istanbul Saglik Bilimleri 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 3 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 6 May 2023. 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?
Percentage of patients needed for rescue analgesic agent (diclofenac) (time frame: 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 6 May 2023.