AnalgesiaNCT05172882
Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
A study testing Wound site infiltration and Transversalis fascia plane block in people with Analgesia and Transversalis Fascia Plane Block, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Analgesia, Transversalis Fascia Plane Block, Wound Infiltration
- What is being tested?
- Wound site infiltration and Transversalis fascia plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Apr 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 who will undergo Varicocele operation
- ASA I-II
Who cannot join
- Patients with allergic reaction to anesthesia and analgesia drugs to be used
- Patients who did not want to voluntarily participate in the study
- Severe systemic disease (kidney, liver, pulmonary, endocrine)
- Substance abuse history
- Chronic pain history
- Psychiatric problems and communication difficulties
- History of hematological problem
- Patients with severe hemodynamic instability due to infection, heavy bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Transversalis Fascia Plane Block and Wound Infiltration in Varicoselectomy Surgery; Randomised, Controlled Study.
Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Postoperative analgesic consumption and pain scores of the patients will be evaluated.
- Being tested
- Wound site infiltration, Transversalis fascia plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound site infiltrationProcedure or surgery
Block fluids that were prepared as 20 ml 0.25% bupivacaine before the intervention, will be applied through the upper and lower incision lips on the suprainguinal surgical site.
Transversalis fascia plane blockProcedure or surgery
External, internal oblique, and transversus abdominis muscles will be visualized by the ultrasound device. After transversalis fascia will be seen, transversalis fascia plane block will be performed. As a block fluid 20 ml 0.25% bupivacaine will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Wound Infiltration | Experimental | Wound infiltration will be applied to the surgical incision site for patients in this group. Infiltration fluid will contain 20 ml 0.25% bupivakain. Receives: Procedure: Wound site infiltration |
| Transversalis Fascia Plane Block | Experimental | Transversalis fascia plane block will be performed on only one periinguinal side for patients in this group. Block fluid will contain 20 ml 0.25% bupivakain. Receives: Procedure: Transversalis fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 1st hour
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 2nd hour
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 4th hour
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 8th hour
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 12th hour
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Measured: 24th hour
Secondary outcomes (1)
Rescue analgesic consumption
Analgesic drug consumption will be assessed
Measured: Any time on postsurgical first 24 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start15 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Cem ÇELİK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172882
- Sponsor's protocol ID
- ATATÜRK ÜNİVERSİTESİ
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Transversalis Fascia Plane Block and Wound Infiltration in Varicoselectomy Surgery; Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT05172882
- Acronym / sponsor ID
- ATATÜRK ÜNİVERSİTESİ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 29 Dec 2021 (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.
Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Postoperative analgesic consumption and pain scores of the patients will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound Infiltration | Experimental | Procedure: Wound site infiltrationWound infiltration will be applied to the surgical incision site for patients in this group. Infiltration fluid will contain 20 ml 0.25% bupivakain. |
| Transversalis Fascia Plane Block | Experimental | Procedure: Transversalis fascia plane blockTransversalis fascia plane block will be performed on only one periinguinal side for patients in this group. Block fluid will contain 20 ml 0.25% bupivakain. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 who will undergo Varicocele operation
- ASA I-II
Key exclusion criteria (8 listed)
- Patients with allergic reaction to anesthesia and analgesia drugs to be used
- Patients who did not want to voluntarily participate in the study
- Severe systemic disease (kidney, liver, pulmonary, endocrine)
- Substance abuse history
- Chronic pain history
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 |
|---|---|---|
| Wound site infiltrationBlock fluids that were prepared as 20 ml 0.25% bupivacaine before the intervention, will be applied through the upper and lower incision lips on the suprainguinal surgical site. | Procedure or surgery | Wound Infiltration |
| Transversalis fascia plane blockExternal, internal oblique, and transversus abdominis muscles will be visualized by the ultrasound device. After transversalis fascia will be seen, transversalis fascia plane block will be performed. As a block fluid 20 ml 0.25% bupivacaine will be applied. | Procedure or surgery | Transversalis Fascia Plane Block |
Primary outcome
Pain Scores (0 (low)-10 (high))
Time frame: 1st hour
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Time frame: 2nd hour
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Time frame: 4th hour
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Time frame: 8th hour
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Time frame: 12th hour
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Time frame: 24th hour
Pain will be assessed by visual analog scale scores
1 secondary outcome
Rescue analgesic consumption
Time frame: Any time on postsurgical first 24 hour.
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 9 Nov 2022.
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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 Wound site infiltration and Transversalis fascia plane block in people with Analgesia and Transversalis Fascia Plane Block, 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 8 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 9 Nov 2022. 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?
Pain Scores (0 (low)-10 (high)) (time frame: 1st hour). The study lists 6 primary outcomes in all. 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 9 Nov 2022.