VaricoceleNCT02983383
Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.
A study testing TAP block group (Group T) and spinal anesthesia in people with Varicocele, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
TAP block is the administration of local anesthetic agents into the anatomic neurofascial cavity between the internal oblique and transversus abdominis muscle in the antero-lateral region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- TAP block group (Group T) and spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to 13 Jun 2018
- 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
- 18-45 year old ASA I-II patient group
Who cannot join
- Contraindications for spinal anesthesia
- Coagulopathy
- Known allergy to medications used
- Infection in the operated area
- Non-volunteer patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46000
About this study
Official title: Effect of TAP Block for Postoperative Pain Control After Varicocele Operations on Analgesia Quality and Postoperative Analgesic Consumption
TAP block is the administration of local anesthetic agents into the anatomic neurofascial cavity between the internal oblique and transversus abdominis muscle in the antero-lateral region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We aim to show the effect of TAP block administration on analgesic consumption after varicocelectomy operations, side effects linked to analgesic use and analgesic quality.
Read the detailed description
The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing varicocelectomy operations under elective conditions, randomized with a lottery method. Patients will be informed of the study and included in the study after giving permission with a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25) and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the medications used, with infection in the operated area, and those who do not volunteer will be excluded from the study. At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4, 6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded. When patients are in pain, analgesic agent will be administered according to patient controlled analgesia protocol. The time of first requirement for analgesic agent and the amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction will be assessed by asking if the surgical method they experienced was bad, moderate, good or very good and recorded.
- Conditions
- Varicocele
- Being tested
- TAP block group (Group T), spinal anesthesia
- Keywords
- Varicocele, TAP block, spinal anesthesia
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block group (Group T)Procedure or surgery
At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
spinal anesthesiaProcedure or surgery
Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).
| Study group | Role | What they receive |
|---|---|---|
| TAP block group (Group T) | Active comparator | At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. Receives: Procedure: TAP block group (Group T) |
| Group without TAP (Group P) | Active comparator | Patients in Group P will have adjuvant added to spinal anesthesia. Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visual analog scale)
VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing
Measured: 24 Hours
Postoperative side effects
questionnaire for postoperative nausea, vomiting, numbness and itching
Measured: 24 Hours
Patient satisfaction
questionnaire for patient satisfaction
Measured: 24 Hours
time to first analgesic
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 posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion18 May 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Boran, Kahramanmaras Sutcu Imam University
- Investigators
- Ömer Faruk Boran, Study chair, Kahramanmaraş Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983383
- Sponsor's protocol ID
- 53
- Status last verified
- Jun 2018
- First submitted
- 30 Nov 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TAP Block for Postoperative Pain Control After Varicocele Operations on Analgesia Quality and Postoperative Analgesic Consumption
- ClinicalTrials.gov ID
- NCT02983383
- Acronym / sponsor ID
- 53
- Conditions
- Varicocele
- Keywords
- Varicocele, TAP block, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
TAP block is the administration of local anesthetic agents into the anatomic neurofascial cavity between the internal oblique and transversus abdominis muscle in the antero-lateral region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We aim to show the effect of TAP block administration on analgesic consumption after varicocelectomy operations, side effects linked to analgesic use and analgesic quality.
Detailed description
The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing varicocelectomy operations under elective conditions, randomized with a lottery method. Patients will be informed of the study and included in the study after giving permission with a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25) and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the medications used, with infection in the operated area, and those who do not volunteer will be excluded from the study. At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4, 6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded. When patients are in pain, analgesic agent will be administered according to patient controlled analgesia protocol. The time of first requirement for analgesic agent and the amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction will be assessed by asking if the surgical method they experienced was bad, moderate, good or very good and recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block group (Group T) | Active comparator | Procedure: TAP block group (Group T)At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. |
| Group without TAP (Group P) | Active comparator | Procedure: spinal anesthesiaPatients in Group P will have adjuvant added to spinal anesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 year old ASA I-II patient group
Key exclusion criteria (5 listed)
- Contraindications for spinal anesthesia
- Coagulopathy
- Known allergy to medications used
- Infection in the operated area
- Non-volunteer patient
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 block group (Group T)At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. | Procedure or surgery | TAP block group (Group T) |
| spinal anesthesiaPatients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey). | Procedure or surgery | Group without TAP (Group P) |
Primary outcome
VAS (visual analog scale)
Time frame: 24 Hours
VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing
Postoperative side effects
Time frame: 24 Hours
questionnaire for postoperative nausea, vomiting, numbness and itching
Patient satisfaction
Time frame: 24 Hours
questionnaire for patient satisfaction
time to first analgesic
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 14 Jun 2018.
- 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 Faruk Boran study chair
Kahramanmaraş Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block group (Group T) and spinal anesthesia in people with Varicocele, run by Kahramanmaras Sutcu Imam 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 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 14 Jun 2018. 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?
VAS (visual analog scale) (time frame: 24 Hours). The study lists 4 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 14 Jun 2018.