Pain, PostoperativeNCT03741452
Transversalis Fascia Plane Block in Caesarean Section Patients
A study testing transversalis fascia plane block in people with Pain, Postoperative, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- transversalis fascia plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2018to 22 Feb 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing cesarean section under general anesthesia ASA I-II
Who cannot join
- patients undergoing cesarean section under neuraxial anesthesia morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University faculty of medicine
Istanbul, 34090
About this study
Official title: Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.
- Conditions
- Pain, Postoperative
- Being tested
- transversalis fascia plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversalis fascia plane blockOther
Also called patient controlled analgesia
patient controlled analgesia devices with tramadol
| Study group | Role | What they receive |
|---|---|---|
| Transversalis fascia plane block | Experimental | The transversalis fascia plane block will be administrated to this group at end of the surgery under general anesthesia. An intravenous patient-controlled analgesia device within tramadol will be given to the patients postoperatively. Receives: Other: transversalis fascia plane block |
| Control group | No intervention | In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with tramadol. No block will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours tramadol consumption
tramadol consumptions for both group will be recorded
Measured: 24 hour
Secondary outcomes (2)
Numeric rating scale for postoperative pain intensity
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 24 hours
Postoperative nausea and vomiting
number of postoperative nasusea and vomiting after surgery will be questioned
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start26 Nov 2018
- Primary completion19 Feb 2019
- Study completion22 Feb 2019
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asst. Prof. Serkan Tulgar, M.D., Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741452
- Sponsor's protocol ID
- TFPB in CS
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Serifsoy TE. Transversalis fascia plane block provides effective postoperative analgesia for cesarean section: New indication for known block. J Clin Anesth. 2018 Aug;48:13-14. doi: 10.1016/j.jclinane.2018.04.006. Epub 2018 Apr 22. No abstract available.
PubMed 29689328Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
PubMed 29164530
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03741452
- Acronym / sponsor ID
- TFPB in CS
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 14 Nov 2018 (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.
Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis fascia plane block | Experimental | Other: transversalis fascia plane blockThe transversalis fascia plane block will be administrated to this group at end of the surgery under general anesthesia. An intravenous patient-controlled analgesia device within tramadol will be given to the patients postoperatively. |
| Control group | No intervention | –In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with tramadol. No block will be performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing cesarean section under general anesthesia ASA I-II
Key exclusion criteria (1 listed)
- patients undergoing cesarean section under neuraxial anesthesia morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs
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 |
|---|---|---|
| transversalis fascia plane blockAlso: patient controlled analgesiapatient controlled analgesia devices with tramadol | Other | Transversalis fascia plane block |
Primary outcome
24 hours tramadol consumption
Time frame: 24 hour
tramadol consumptions for both group will be recorded
2 secondary outcomes
Numeric rating scale for postoperative pain intensity
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 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 25 Feb 2019.
- Background: PubMed 29689328Tulgar S, Serifsoy TE. Transversalis fascia plane block provides effective postoperative analgesia for cesarean section: New indication for known block. J Clin Anesth. 2018 Aug;48:13-14. doi: 10.1016/j.jclinane.2018.04.006. Epub 2018 Apr 22. No abstract available.
- Background: PubMed 29164530Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
- 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 study testing transversalis fascia plane block in people with Pain, Postoperative, run by Maltepe 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 1 inclusion and 1 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 25 Feb 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. 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?
24 hours tramadol consumption (time frame: 24 hour). 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 NCT03741452, 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 25 Feb 2019.