Primary Inguinal HerniaERA-TAPPNCT06406959
The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)
A study testing Transversus abdominal plane block (TAP block) in people with Primary Inguinal Hernia, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Inguinal Hernia
- What is being tested?
- Transversus abdominal plane block (TAP block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2024to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral primary inguinal hernia who are scheduled for elective Transabdominal preperitoneal inguinal hernia repair (TAPP)
- Signed Informed consent to participation
- ASA I-III
- BMI ≤35 kg/m2
- Non-inclusion Criteria:
- Inguinoscrotal hernia (hernia passing through the entrance to the scrotum)
Show all 9Show fewer
- Previously diagnosed mental disorders
- Patients receiving psychotropic drugs and drugs affecting adrenal cortex function (estrogens and systemic glucocorticoids)
- Language barrier
Who cannot join
- Deviations during the operation/anesthesia that required transfer to the intensive care unit or conversion to open surgery
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Department of faculty surgery №1 Pirogov Russian National Research Medical University
Moscow, 117997
Taras Nechay, MD, +79268146829, tnechay@mail.ru
About this study
Official title: The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - a Randomized Controlled Trial
The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair.
Read the detailed description
Inguinal hernia repair is one of the most common elective interventions in general surgery. Approximately 20 million inguinal hernia repairs are performed worldwide every year. Laparo-endoscopic techniques provide faster recovery times, lower chronic pain risk and are cost effective compared to open one.
Nevertheless, laparoscopic inguinal hernia repair can result in moderate to severe pain in the early postoperative period, interfering the time of returning to normal activity in a substantial quantity of patients. To reduce pain and to accelerate recovery, local and regional anesthetics has been successfully implemented into the daily routine of abdominal surgeries.
Recent systematic reviews have shown that TAP block can reduce analgetic consumption and acute pain scores after inguinal hernia repair. However, most included studies were conducted on patients with open hernia surgery or total extra peritoneal (TEP) inguinal hernia repair. Some studies showed the benefit of TAP block for early pain control following TAPP. Most of them were retrospective, some conducted with exclusion of obese or comorbid patients, some in mixed groups without separating patients with TAPP and TEP.
Thus, the evidence of TAP block efficiency prior to hernia repair in TAPP technique are of low quality.
Chronic postoperative inguinal pain (CPIP) develops in up to 6% of patients after TAPP. Several studies have found that intense acute postoperative pain is a risk factor for CPIP after IHR. The investigators hypothesize, that preemptive TAP block temporary stops nociception and central sensitization from the surgical site thus reduce acute postoperative pain that theoretically provoke reducing the incidence of CPIP following IHR. Two studies suggest that TAP block may influence the incidence of CPIP after TAPP. Considering the retrospective study design of both and the insufficient sample size further randomized clinical trials are mandatory to estimate this hypothesis.
The aim of our study is to explore the possibilities of reducing acute and chronic pain after TAPP via implementation TAP block.
The sample size was calculated based on the randomized controlled trial data of patients after TEP IHR where postoperative VAS score at 4 h on coughing was 4.7±1.5 in the preemptive local anesthesia group and 6.1±1.9 in the control group. A sample size of 39 patients was required for each subgroup (total=78 patients) with a type I error rate α=0.05 and type II error rate β=0.1.
- Conditions
- Primary Inguinal Hernia
- Being tested
- Transversus abdominal plane block (TAP block)
- Keywords
- transverse abdominis plane block, inguinal hernia, TAPP technique, chronic postoperative pain, acute pain, inguinal hernia surgery
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominal plane block (TAP block)Procedure or surgery
Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision
| Study group | Role | What they receive |
|---|---|---|
| TAP-block | Experimental | TAPP inguinal hernia repair under general anesthesia with endotracheal intubation. Patients receive unilateral US-guided TAP-block with 20 ml 0,375% Levobupivacaine before incision Receives: Procedure: Transversus abdominal plane block (TAP block) |
| Standard care | No intervention | TAPP inguinal hernia repair under general anesthesia with endotracheal intubation (without preemptive regional anesthesia) in accordance with actual standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain 4h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Measured: 4±1 hours postop
Secondary outcomes (11)
Acute postoperative pain 2h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Measured: 2±1 hours postop
Acute postoperative pain 6h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Measured: 6±1 hours postop
Number of Participants meeting discharge criteria
Blood pressure ≥100/60 mm Hg; Activation within the department; Ability to oral medication (no postoperative nausea and vomiting); Pain (NRS) ≤3 points; No signs of complications (bleeding, early relapse)
Measured: 6±1 hours postop
Analgetic consumption (dose quantity)
At NRS score 4-6 at rest patients receive: 30mg Ketorolak IV no more than once every 8 hours or 1000mg Acetaminophen IV no more than once every 6 hours; At NRS score ≥7 at rest patients receive 100 mg Tramadol IV no more than once every 12 hours; The number of analgesic doses administered is counted.
Measured: 24 hours postop
Concentration of serum cortisol
nmol/L
Measured: At 8 am on the day of surgery, 4±1 hours postop
Acute postoperative pain 24h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Participants verbally requested to rate their pain: "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: 24±3 hours postop
Length of stay
Days
Measured: From date of hospitalization until the date of discharge
Number of Participants with postoperative complications
Number of Participants with postoperative complications, evaluated by Clavien-Dindo classification (telephone survey)
Measured: Postoperative 30 (±3) days
Patient satisfaction score
Patient satisfaction with treatment is assessed by telephone survey using the Linkert-type scale (1 - less satisfaction, 5 - more satisfaction)
Measured: Postoperative 30 (±3) days
Number of Participants with chronic pain
Pain score will be assessed by NRS (telephone survey). Participants verbally requested to rate their pain: "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: Postoperative 90 (±3) days
Number of Participants with recurrence
Participants undergo a telephone survey. Participants presenting with characteristic complaints are invited for examination and ultrasound scan.
Measured: After 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary Inguinal HerniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taras V. Nechay, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406959
- Sponsor's protocol ID
- 2
- Acronym
- ERA-TAPP
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aasvang EK, Gmaehle E, Hansen JB, Gmaehle B, Forman JL, Schwarz J, Bittner R, Kehlet H. Predictive risk factors for persistent postherniotomy pain. Anesthesiology. 2010 Apr;112(4):957-69. doi: 10.1097/ALN.0b013e3181d31ff8.
PubMed 20234307Arora S, Chhabra A, Subramaniam R, Arora MK, Misra MC, Bansal VK. Transversus abdominis plane block for laparoscopic inguinal hernia repair: a randomized trial. J Clin Anesth. 2016 Sep;33:357-64. doi: 10.1016/j.jclinane.2016.04.047. Epub 2016 May 28.
PubMed 27555193Chamzin A, Frountzas M, Gkiokas G, Kouskouni E, Xanthos T, Michalopoulos NV. The Effect of Intraoperative Transversus Abdominis Plane Blocking on Postoperative Pain After Laparoscopic Transabdominal Pre-peritoneal (TAPP) Groin Hernia Repair. Front Surg. 2022 Feb 8;9:834050. doi: 10.3389/fsurg.2022.834050. eCollection 2022.
PubMed 35211504Gao T, Zhang JJ, Xi FC, Shi JL, Lu Y, Tan SJ, Yu WK. Evaluation of Transversus Abdominis Plane (TAP) Block in Hernia Surgery: A Meta-analysis. Clin J Pain. 2017 Apr;33(4):369-375. doi: 10.1097/AJP.0000000000000412.
PubMed 27518492Hosni M, Soulios, JP, Francart, D. Ultrasound transversus abdominis plane (TAP) block versus local infiltration analgesia for acute and chronic postoperative pain control after laparoscopic bilateral hernia repair: a single-center randomized controlled trial. Acta Anaesthesiologica Belgica. 2020; 71(4), 171-174. https://doi.org/10.56126/71.4.2
Hubbard G, Hubert C, Vudayagiri L, Tullington J, Merino K, Vaidya A, Gemma R. Transversus abdominis plane blocks in laparoscopic inguinal hernia repair: a review. Hernia. 2023 Oct;27(5):1059-1065. doi: 10.1007/s10029-023-02831-x. Epub 2023 Jul 3.
PubMed 37395916HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
PubMed 29330835Kim MG, Kim SI, Ok SY, Kim SH, Lee SJ, Park SY, Lee SM, Jung BI. The analgesic effect of ultrasound-guided transverse abdominis plane block after laparoscopic totally extraperitoneal hernia repair. Korean J Anesthesiol. 2012 Sep;63(3):227-32. doi: 10.4097/kjae.2012.63.3.227. Epub 2012 Sep 14.
PubMed 23060979Paasch C, Fiebelkorn J, Berndt N, De Santo G, Aljedani N, Ortiz P, Gauger U, Boettge K, Anders S, Full H, Strik MW. The transversus abdominis plane block reduces the cumulative need of analgesic medication following inguinal hernia repair in TAPP technique: a retrospective single center analysis among 838 patients. Hernia. 2020 Dec;24(6):1371-1378. doi: 10.1007/s10029-020-02156-z. Epub 2020 Mar 13.
PubMed 32170456Paasch C, Fiebelkorn J, De Santo G, Azarhoush S, Boettge K, Anders S, Gauger U, Strik M. The transversus abdominis plane block may reduce chronic postoperative pain one year after TAPP ingunial hernia repair. Ann Med Surg (Lond). 2020 May 23;55:190-194. doi: 10.1016/j.amsu.2020.04.011. eCollection 2020 Jul.
PubMed 32518639Reinpold W. Risk factors of chronic pain after inguinal hernia repair: a systematic review. Innov Surg Sci. 2017 May 12;2(2):61-68. doi: 10.1515/iss-2017-0017. eCollection 2017 Jun.
PubMed 31579738Takebayashi K, Matsumura M, Kawai Y, Hoashi T, Katsura N, Fukuda S, Shimizu K, Inada T, Sato M. Efficacy of transversus abdominis plane block and rectus sheath block in laparoscopic inguinal hernia surgery. Int Surg. 2015 Apr;100(4):666-71. doi: 10.9738/INTSURG-D-14-00193.1.
PubMed 25875548
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06406959
- Acronym / sponsor ID
- ERA-TAPP / 2
- Conditions
- Primary Inguinal Hernia
- Keywords
- transverse abdominis plane block, inguinal hernia, TAPP technique, chronic postoperative pain, acute pain, inguinal hernia surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 May 2024 (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.
The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair.
Detailed description
Inguinal hernia repair is one of the most common elective interventions in general surgery. Approximately 20 million inguinal hernia repairs are performed worldwide every year. Laparo-endoscopic techniques provide faster recovery times, lower chronic pain risk and are cost effective compared to open one.
Nevertheless, laparoscopic inguinal hernia repair can result in moderate to severe pain in the early postoperative period, interfering the time of returning to normal activity in a substantial quantity of patients. To reduce pain and to accelerate recovery, local and regional anesthetics has been successfully implemented into the daily routine of abdominal surgeries.
Recent systematic reviews have shown that TAP block can reduce analgetic consumption and acute pain scores after inguinal hernia repair. However, most included studies were conducted on patients with open hernia surgery or total extra peritoneal (TEP) inguinal hernia repair. Some studies showed the benefit of TAP block for early pain control following TAPP. Most of them were retrospective, some conducted with exclusion of obese or comorbid patients, some in mixed groups without separating patients with TAPP and TEP.
Thus, the evidence of TAP block efficiency prior to hernia repair in TAPP technique are of low quality.
Chronic postoperative inguinal pain (CPIP) develops in up to 6% of patients after TAPP. Several studies have found that intense acute postoperative pain is a risk factor for CPIP after IHR. The investigators hypothesize, that preemptive TAP block temporary stops nociception and central sensitization from the surgical site thus reduce acute postoperative pain that theoretically provoke reducing the incidence of CPIP following IHR. Two studies suggest that TAP block may influence the incidence of CPIP after TAPP. Considering the retrospective study design of both and the insufficient sample size further randomized clinical trials are mandatory to estimate this hypothesis.
The aim of our study is to explore the possibilities of reducing acute and chronic pain after TAPP via implementation TAP block.
The sample size was calculated based on the randomized controlled trial data of patients after TEP IHR where postoperative VAS score at 4 h on coughing was 4.7±1.5 in the preemptive local anesthesia group and 6.1±1.9 in the control group. A sample size of 39 patients was required for each subgroup (total=78 patients) with a type I error rate α=0.05 and type II error rate β=0.1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP-block | Experimental | Procedure: Transversus abdominal plane block (TAP block)TAPP inguinal hernia repair under general anesthesia with endotracheal intubation. Patients receive unilateral US-guided TAP-block with 20 ml 0,375% Levobupivacaine before incision |
| Standard care | No intervention | –TAPP inguinal hernia repair under general anesthesia with endotracheal intubation (without preemptive regional anesthesia) in accordance with actual standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with unilateral primary inguinal hernia who are scheduled for elective Transabdominal preperitoneal inguinal hernia repair (TAPP)
- Signed Informed consent to participation
- ASA I-III
- BMI ≤35 kg/m2
- Inguinoscrotal hernia (hernia passing through the entrance to the scrotum)
Key exclusion criteria (2 listed)
- Deviations during the operation/anesthesia that required transfer to the intensive care unit or conversion to open surgery
- Refusal to participate
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 |
|---|---|---|
| Transversus abdominal plane block (TAP block)Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision | Procedure or surgery | TAP-block |
Primary outcome
Acute postoperative pain 4h
Time frame: 4±1 hours postop
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
11 secondary outcomes
Acute postoperative pain 2h
Time frame: 2±1 hours postop
Acute postoperative pain 6h
Time frame: 6±1 hours postop
Number of Participants meeting discharge criteria
Time frame: 6±1 hours postop
Analgetic consumption (dose quantity)
Time frame: 24 hours postop
Concentration of serum cortisol
Time frame: At 8 am on the day of surgery, 4±1 hours postop
Acute postoperative pain 24h
Time frame: 24±3 hours postop
Length of stay
Time frame: From date of hospitalization until the date of discharge
Number of Participants with postoperative complications
Time frame: Postoperative 30 (±3) days
Patient satisfaction score
Time frame: Postoperative 30 (±3) days
Number of Participants with chronic pain
Time frame: Postoperative 90 (±3) days
Number of Participants with recurrence
Time frame: After 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 20234307Aasvang EK, Gmaehle E, Hansen JB, Gmaehle B, Forman JL, Schwarz J, Bittner R, Kehlet H. Predictive risk factors for persistent postherniotomy pain. Anesthesiology. 2010 Apr;112(4):957-69. doi: 10.1097/ALN.0b013e3181d31ff8.
- Background: PubMed 27555193Arora S, Chhabra A, Subramaniam R, Arora MK, Misra MC, Bansal VK. Transversus abdominis plane block for laparoscopic inguinal hernia repair: a randomized trial. J Clin Anesth. 2016 Sep;33:357-64. doi: 10.1016/j.jclinane.2016.04.047. Epub 2016 May 28.
- Background: PubMed 35211504Chamzin A, Frountzas M, Gkiokas G, Kouskouni E, Xanthos T, Michalopoulos NV. The Effect of Intraoperative Transversus Abdominis Plane Blocking on Postoperative Pain After Laparoscopic Transabdominal Pre-peritoneal (TAPP) Groin Hernia Repair. Front Surg. 2022 Feb 8;9:834050. doi: 10.3389/fsurg.2022.834050. eCollection 2022.
- Background: PubMed 27518492Gao T, Zhang JJ, Xi FC, Shi JL, Lu Y, Tan SJ, Yu WK. Evaluation of Transversus Abdominis Plane (TAP) Block in Hernia Surgery: A Meta-analysis. Clin J Pain. 2017 Apr;33(4):369-375. doi: 10.1097/AJP.0000000000000412.
- BackgroundHosni M, Soulios, JP, Francart, D. Ultrasound transversus abdominis plane (TAP) block versus local infiltration analgesia for acute and chronic postoperative pain control after laparoscopic bilateral hernia repair: a single-center randomized controlled trial. Acta Anaesthesiologica Belgica. 2020; 71(4), 171-174. https://doi.org/10.56126/71.4.2
- Background: PubMed 37395916Hubbard G, Hubert C, Vudayagiri L, Tullington J, Merino K, Vaidya A, Gemma R. Transversus abdominis plane blocks in laparoscopic inguinal hernia repair: a review. Hernia. 2023 Oct;27(5):1059-1065. doi: 10.1007/s10029-023-02831-x. Epub 2023 Jul 3.
- Background: PubMed 29330835HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
- Background: PubMed 23060979Kim MG, Kim SI, Ok SY, Kim SH, Lee SJ, Park SY, Lee SM, Jung BI. The analgesic effect of ultrasound-guided transverse abdominis plane block after laparoscopic totally extraperitoneal hernia repair. Korean J Anesthesiol. 2012 Sep;63(3):227-32. doi: 10.4097/kjae.2012.63.3.227. Epub 2012 Sep 14.
- Background: PubMed 32170456Paasch C, Fiebelkorn J, Berndt N, De Santo G, Aljedani N, Ortiz P, Gauger U, Boettge K, Anders S, Full H, Strik MW. The transversus abdominis plane block reduces the cumulative need of analgesic medication following inguinal hernia repair in TAPP technique: a retrospective single center analysis among 838 patients. Hernia. 2020 Dec;24(6):1371-1378. doi: 10.1007/s10029-020-02156-z. Epub 2020 Mar 13.
- Background: PubMed 32518639Paasch C, Fiebelkorn J, De Santo G, Azarhoush S, Boettge K, Anders S, Gauger U, Strik M. The transversus abdominis plane block may reduce chronic postoperative pain one year after TAPP ingunial hernia repair. Ann Med Surg (Lond). 2020 May 23;55:190-194. doi: 10.1016/j.amsu.2020.04.011. eCollection 2020 Jul.
- Background: PubMed 31579738Reinpold W. Risk factors of chronic pain after inguinal hernia repair: a systematic review. Innov Surg Sci. 2017 May 12;2(2):61-68. doi: 10.1515/iss-2017-0017. eCollection 2017 Jun.
- Background: PubMed 25875548Takebayashi K, Matsumura M, Kawai Y, Hoashi T, Katsura N, Fukuda S, Shimizu K, Inada T, Sato M. Efficacy of transversus abdominis plane block and rectus sheath block in laparoscopic inguinal hernia surgery. Int Surg. 2015 Apr;100(4):666-71. doi: 10.9738/INTSURG-D-14-00193.1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominal plane block (TAP block) in people with Primary Inguinal Hernia, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 9 inclusion and 2 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 9 May 2024. 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 Russia. 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 Taras Nechay, MD (+79268146829, tnechay@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain 4h (time frame: 4±1 hours postop). 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 NCT06406959, which also lists 12 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 9 May 2024.