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).
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
- 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
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 group | Role | What they receive |
|---|---|---|
| Group T | Active comparator | At 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 Q | Active comparator | At 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 C | No intervention | In 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.
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)
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.
- First posted4 Jan 2019
- Study start25 Dec 2018
- Primary completion25 Apr 2020 (estimated)
- Study completion25 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Model description
- Patients undergoing varicocele surgery under spinal anesthesia
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ömer Faruk Boran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ömer Faruk Boran, Kahramanmaras Sutcu Imam University
- Investigators
- Ömer F Boran, Principal investigator, Bay
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of TAP Block and QL Block on Postoperative Analgesic Consumption and Patient Satisfaction After Varicocele Surgery
- ClinicalTrials.gov ID
- NCT03793764
- Acronym / sponsor ID
- 2018/15/21
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ömer Faruk BoranUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 25 Apr 2020 (estimated)
- Study completion
- 25 Jun 2020 (estimated)
- First posted
- 4 Jan 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients undergoing varicocele surgery under spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| Group T | Active comparator | Procedure: TAP blockAt the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine. |
| Group Q | Active comparator | Procedure: QL blockAt the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine. |
| Group C | No intervention | –In this group no intervention will be performed after the end of operation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA 1-2
- Patients undergoing varicocele surgery
Key exclusion criteria (4 listed)
- Patient refusal
- Coagulation abnormality.
- contraindication for spinal anesthesia
- Failed block
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 |
|---|---|---|
| TAP blockUSG guided TAP block | Procedure or surgery | Group T |
| QL blockUSG guided QL block | Procedure or surgery | Group Q |
Primary outcome
Postoperative analgesic consumption
Time frame: postoperative 24 hours
The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.
1 secondary outcome
Patient satisfacion
Time frame: postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
Ömer F Boran principal investigator
Bay
2 sites in 1 country: see every site and its status.
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.