Caesarean SectionPhase 4NCT04172727
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section
A Phase 4 study testing Bupivacaine Hcl 0.25% Inj and saline 0.9% in people with Caesarean Section and Pain, Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. 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
- Caesarean Section, Pain, Acute
- What is being tested?
- Bupivacaine Hcl 0.25% Inj and saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jun 2019
- Phase
- Phase 4
- 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
- aged between 18 and 45
- American Society of Anesthesiologists (ASA) physical score I or II
Who cannot join
- Patients who received general anesthesia
- hypersensitivity to the agents to be used
- body mass index (BMI) greater than 35 kg/m2
- coagulopathy
- local infections
- opioid addiction
- pregnancy-related hypertension or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study
Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.
- Conditions
- Caesarean Section, Pain, Acute
- Being tested
- Bupivacaine Hcl 0.25% Inj, saline 0.9%
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hcl 0.25% InjDrug
ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine
saline 0.9%Drug
ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided transversalis fascia plane block | Active comparator | 20 mL of 0.25% bupivacaine Receives: Drug: Bupivacaine Hcl 0.25% Inj |
| ultrasound guided sham block | Placebo comparator | 20 mL of saline Receives: Drug: saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
morphine consumption first 24hour
Measured: Postoperative first 24hour
Secondary outcomes (1)
pain scores
Visual Analogue Scale (0-10)
Measured: postoperative 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jan 2019
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172727
- Sponsor's protocol ID
- AUTF ANESTHESIAOBSTETRIC
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.
PubMed 31255890Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
PubMed 19495909Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
PubMed 32412986
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT04172727
- Acronym / sponsor ID
- AUTF ANESTHESIAOBSTETRIC
- Conditions
- Caesarean Section, Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Nov 2019 (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 pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided transversalis fascia plane block | Active comparator | Drug: Bupivacaine Hcl 0.25% Inj20 mL of 0.25% bupivacaine |
| ultrasound guided sham block | Placebo comparator | Drug: saline 0.9%20 mL of saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged between 18 and 45
- American Society of Anesthesiologists (ASA) physical score I or II
Key exclusion criteria (7 listed)
- Patients who received general anesthesia
- hypersensitivity to the agents to be used
- body mass index (BMI) greater than 35 kg/m2
- coagulopathy
- local infections
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 |
|---|---|---|
| Bupivacaine Hcl 0.25% Injultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine | Drug | ultrasound guided transversalis fascia plane block |
| saline 0.9%ultrasound-guided bilateral TFP block with 20 mL of saline 0.9% | Drug | ultrasound guided sham block |
Primary outcome
opioid consumption
Time frame: Postoperative first 24hour
morphine consumption first 24hour
1 secondary outcome
pain scores
Time frame: postoperative 0-24 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 21 Nov 2019.
- Background: PubMed 31255890Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.
- Background: PubMed 19495909Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
- Derived from this study: PubMed 32412986Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
- 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. 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 Phase 4 study testing Bupivacaine Hcl 0.25% Inj and saline 0.9% in people with Caesarean Section and Pain, Acute, run by Ataturk 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 21 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
opioid consumption (time frame: Postoperative first 24hour). 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 NCT04172727, which also lists 3 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 21 Nov 2019.