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InfertilityNCT03793764

Comparison of TAP Bock vs QL Block in Varicocele Surgery

A study testing TAP block and QL block in people with Infertility, run by Ömer Faruk Boran at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study we aim to compare the effect of TAP block and QL block on postoperative analgesia, analgesic consumption , side effects and patient satisfaction after varicocelec surgery. Read more about this study

Who is it for?
Ages 18 to 45 years, men only
Conditions the study is for
Infertility
What is being tested?
TAP block and QL block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesTurkey (Türkiye)
Study dates
25 Dec 2018to 25 Jun 2020
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
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • ASA 1-2
  • Patients undergoing varicocele surgery

Who cannot join

  • Patient refusal
  • Coagulation abnormality.
  • contraindication for spinal anesthesia
  • Failed block

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites, 2 recruiting
  • Kahramanmaras Sutcu Imam University

    Kahramanmaraş, 46000

    Ömer Faruk Boran, +903442803434 ext. 3796, omerfarukboran@hotmail.com

    Ömer Faruk Boran

    Recruiting
  • Kahramanmaraş Sütçü Imam Üniversity

    Kahramanmaraş, 46000

    Ömer Faruk Boran, 3442803796 ext. 3796, omerfarukboran@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Comparison of TAP Block and QL Block on Postoperative Analgesic Consumption and Patient Satisfaction After Varicocele Surgery

In this study we aim to compare the effect of TAP block and QL block on postoperative analgesia, analgesic consumption , side effects and patient satisfaction after varicocelec surgery.

75 patients will be randomized into 3 groups:TAP Group (Group T) n = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25 All patients will be operated on with spinal anesthesia. TAP and QL blocks will be performed after completion of the surgeries. In the postoperative care unit, an iv patient-controlled analgesia protocol with tramadol will be started. Patients in all three groups will be assessed with a resting and cough VAS (visual analog scale) at postoperative 2,4,6,12,18 and 24 hours and values will be recorded. The amount of analgesic consumption and the first analgesic request times will be recorded. Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed with these methods as bad, medium, good, and very good.

Read the detailed description

Purpose:TAP is the application of local anesthetic agents to block the anterior neck of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves in the anatomic neurofascial gap between the internal oblique and transversus abdominis muscle located in the anterolateral region of the abdomen. It was first described by Rafi in 2001. Then in 2007 Hebbart et al. described that using USG, TAP block could be implemented more effectively and safely. With QL block, a local anesthetic agent is applied to the posterior layer of the thoracolumbar fascia and similar nerve blockage is achieved. The technique was first described by Blanco in 2007. TAP block and QL block may be a good method for postoperative pain control. We aimed to compare the efficacy of TAP block and QL block to analgesic consumption after varicocelectomy operations, analgesic side effects and analgesia quality and to compare these two block efficacy.

Material \& Method:75 patients in the ASA I-II risk group, aged 18-45 years, who will undergo elective varicocelectomy surgery, will be randomized using the cohort procedure. The patient will be informed about the study and will be included in the study after the patient is approved with the approval form. The three groups will be divided into TAP Group (Group T) n = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25. A total of 75 patients were planned to receive α = 0,05 at the β: 0.20 level and 0.80 at the power level and n = 25 for each group. Reference work including VAS scores and I-TAP method was taken into consideration when the sample size of the study was determined. The normal distribution of data in the statistical evaluation of the study will be examined by the Shapiro-Wilk test. One-way ANOVA will be performed for comparison of groups (if the data are normally distributed). Multiple comparisons Tukey test, Dunnett test Tamhane T2 test will be applied. (Kruskal-Wallis H test will be applied in cases where it does not normally disperse.) Multiple comparison will be performed with the Dunn-Sidak test. Statistical significance is accepted as p <0.05, data will be examined in the IBMSPSS program. All three patients will be operated on with spinal anesthesia. Patients with coagulopathy who are contraindicated for spinal anesthesia, known allergies to the drugs to be used, infected and non-voluntary patients to be excluded from the study. At the end of the disease operation in Group T, after the necessary antiseptic conditions are established in the supine position, the USG probe midpoint (within the petit triangle). After the abdominal muscle layers are seen, the facial muscle sensation is taken when the needle-like muscular layers and facial muscles pass, and the needle is controlled with USG. After receiving the second click feeling (passage of the internalocutaneous fascia), the needle-like localization will be determined by applying a test dose of 0.5-1 ml. After localization is confirmed, frequent aspiration and local anesthetic agent will be given to the neurophysiologic plan and TAP block will be applied. To apply the lateral QL block to the patient in Group Q, a low frequency convex probe is inserted into the patient while the patient is in the supine position. Quadratus lumborum block 1 is injected with 20 mL of local anesthetic on the lateral side of the QL muscle in the area where the transversus abdominis muscle contacts the transversal fascia at the level that enters the aponeurope. Local analgesics will not be administered with Group III disease needle. When the patient is removed to the postoperative care unit, an iv patient-controlled analgesia device will be applied. Patients in all three groups will be assessed with a resting and cough VAS (visual analog scale) at postoperative 2,4,6,12,18 and 24 hours (pain intensity: 0 no pain and 10: the most severe pain I have ever heard) and values will be recorded. When the patient has a pain, an analgesic agent will be given according to the patient-controlled analgesia protocol. The amount of analgesic agent consumed by the patients when the first analgesic agent is needed and 24 hours will be recorded. Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed with these methods as bad, medium, good, and very good.

Conditions
Infertility
Being tested
TAP block, QL block
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP blockProcedure or surgery

    USG guided TAP block

  • QL blockProcedure or surgery

    USG guided QL block

Study groups in NCT03793764
Study groupRoleWhat they receive
Group TActive comparatorAt the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine.
Receives: Procedure: TAP block
Group QActive comparatorAt the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine.
Receives: Procedure: QL block
Group CNo interventionIn this group no intervention will be performed after the end of operation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative analgesic consumption

    The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.

    Measured: postoperative 24 hours

Secondary outcomes (1)
  1. Patient satisfacion

    Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.

    Measured: postoperative 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start25 Dec 2018
  3. Primary completion25 Apr 2020 (estimated)
  4. Study completion25 Jun 2020 (estimated)

Resources

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
Model description
Patients undergoing varicocele surgery under spinal anesthesia
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793764
Sponsor's protocol ID
2018/15/21
Status last verified
Nov 2019
First submitted
26 Dec 2018
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TAP block and QL block in people with Infertility, run by Ömer Faruk Boran at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 18 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 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ömer F Boran (03442803796, omerfarukboran@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative analgesic consumption (time frame: postoperative 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 18 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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