Anesthesia; SexualNCT05758233
The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section
A study testing Patients undergoing transversalis fascia plane block and Patients undergoing transversus abdominis plane block in people with Anesthesia; Sexual and Analgesia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Sexual, Analgesia
- What is being tested?
- Patients undergoing transversalis fascia plane block and Patients undergoing transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2022to 30 Jun 2022
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-50 years old pregnant woman
- ASAII-III
- Patients accepting spinal anesthesia
Who cannot join
- Morbid obesity(BMI >40)
- Patients who are switched to general anesthesia in an unexpected perioperative situation
- Patients with placental anomaly
- Patients with bupivacaine allergy
- Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Basaksehir, 3268
About this study
Official title: Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial
The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.
The main question[s] it aims to answer are:
[Is transversalis fascia plane block more effective in postoperative analgesia? ]
[Is there a difference between the duration of postoperative first analgesia requirement? ] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.
Read the detailed description
This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .
- Conditions
- Anesthesia; Sexual, Analgesia
- Being tested
- Patients undergoing transversalis fascia plane block, Patients undergoing transversus abdominis plane block
- Keywords
- anesthesia recovery period, cesarean section, obstetric anesthesia, spinal anaesthesia, postoperative analgesia
- Medical subject headings
- Coitus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing transversalis fascia plane blockProcedure or surgery
The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
Patients undergoing transversus abdominis plane blockProcedure or surgery
The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Grup 1: Transversalis Fascia Plane Block (TFPB) | Experimental | Transversalis Fascia Plane Block (TFPB) Receives: Procedure: Patients undergoing transversalis fascia plane block; Procedure: Patients undergoing transversus abdominis plane block |
| Grup 2: Transversus Abdominis Plane Block (TAPB) | Experimental | Transversus Abdominis Plane Block (TAPB) Receives: Procedure: Patients undergoing transversalis fascia plane block; Procedure: Patients undergoing transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of first analgesic need
Our primary goal was to meet the initial analgesic requirement times.
Measured: 24 hours postoperatively
Secondary outcomes (1)
visuel analog scale
Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start4 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Anesthesia; SexualStudies 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
- Model description
- Prospective randomize study
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Duygu Akyol, M.D, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758233
- Sponsor's protocol ID
- 2022-74
- Status last verified
- Jul 2023
- First submitted
- 20 Feb 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.
PubMed 35455750Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.
PubMed 31653797
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05758233
- Acronym / sponsor ID
- 2022-74
- Conditions
- Anesthesia; Sexual, Analgesia
- Keywords
- anesthesia recovery period, cesarean section, obstetric anesthesia, spinal anaesthesia, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Mar 2023 (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.
The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.
The main question[s] it aims to answer are:
[Is transversalis fascia plane block more effective in postoperative analgesia? ]
[Is there a difference between the duration of postoperative first analgesia requirement? ] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.
Detailed description
This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomize study
| Arm | Type | Receives |
|---|---|---|
| Grup 1: Transversalis Fascia Plane Block (TFPB) | Experimental | Procedure: Patients undergoing transversalis fascia plane block, Procedure: Patients undergoing transversus abdominis plane blockTransversalis Fascia Plane Block (TFPB) |
| Grup 2: Transversus Abdominis Plane Block (TAPB) | Experimental | Procedure: Patients undergoing transversalis fascia plane block, Procedure: Patients undergoing transversus abdominis plane blockTransversus Abdominis Plane Block (TAPB) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-50 years old pregnant woman
- ASAII-III
- Patients accepting spinal anesthesia
Key exclusion criteria (5 listed)
- Morbid obesity(BMI >40)
- Patients who are switched to general anesthesia in an unexpected perioperative situation
- Patients with placental anomaly
- Patients with bupivacaine allergy
- Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia
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 |
|---|---|---|
| Patients undergoing transversalis fascia plane blockThe investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain. | Procedure or surgery | Grup 1: Transversalis Fascia Plane Block (TFPB), Grup 2: Transversus Abdominis Plane Block (TAPB) |
| Patients undergoing transversus abdominis plane blockThe investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain. | Procedure or surgery | Grup 1: Transversalis Fascia Plane Block (TFPB), Grup 2: Transversus Abdominis Plane Block (TAPB) |
Primary outcome
time of first analgesic need
Time frame: 24 hours postoperatively
Our primary goal was to meet the initial analgesic requirement times.
1 secondary outcome
visuel analog scale
Time frame: 24 hours postoperatively
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 17 Jul 2023.
- Background: PubMed 35455750Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.
- Results publication: PubMed 31653797Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.
- 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.
Duygu Akyol, M.D principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients undergoing transversalis fascia plane block and Patients undergoing transversus abdominis plane block in people with Anesthesia; Sexual and Analgesia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 5 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 17 Jul 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?
time of first analgesic need (time frame: 24 hours postoperatively). 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 NCT05758233, 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 17 Jul 2023.