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Inguinal Hernia RepairVIS-TAP-TAPPNCT07264699

Visually Guided TAP Block in Laparoscopic TAPP Hernia Repair

A study testing Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine in people with Inguinal Hernia Repair and Postoperative Pain, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, randomized clinical study aims to evaluate the effectiveness of the Transversus Abdominis Plane (TAP) block performed under direct laparoscopic vision in reducing postoperative pain and improving recovery after laparoscopic inguinal hernia repair using the TAPP (Transabdominal Preperitoneal)… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePoland
Study dates
4 Dec 2025to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years
  • Elective laparoscopic inguinal hernia repair using the TAPP (Transabdominal Preperitoneal) technique
  • ASA physical status I-III
  • Ability to provide written informed consent
  • No contraindications to regional anesthesia or local anesthetic administration

Who cannot join

  • Recurrent or strangulated inguinal hernia
  • Emergency surgery
  • Chronic pain syndromes or preoperative opioid use
  • Known allergy or hypersensitivity to local anesthetics (bupivacaine or similar)
  • Severe hepatic or renal impairment
  • Psychiatric disorders or inability to provide informed consent
  • Conversion to open surgery during the procedure
  • Technical difficulties preventing TAP block administration

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Łukasz Dyśko, MD contact

+48895245341

lukaszdysko@gmail.com

Poland1 site, 1 recruiting
  • University Clinical Hospital in Olsztyn, Department of General and Oncological Surgery

    Olsztyn, Warmisko-mazurskie, 10-041

    Marek Kowalczyk, PhD, MD, +48895245341, makarek2009@wp.pl

    Recruiting

Other trials in Poland

About this study

Official title: Efficacy of Visually Guided Transversus Abdominis Plane (TAP) Block in Recovery After Laparoscopic Inguinal Hernia Repair (TAPP - Transabdominal Preperitoneal)

This prospective, randomized clinical study aims to evaluate the effectiveness of the Transversus Abdominis Plane (TAP) block performed under direct laparoscopic vision in reducing postoperative pain and improving recovery after laparoscopic inguinal hernia repair using the TAPP (Transabdominal Preperitoneal) technique.

The study will enroll 100 adult patients undergoing elective laparoscopic TAPP hernia repair at the University Clinical Hospital in Olsztyn, Poland. Participants will be randomly assigned to two equal groups. In the study group, a bilateral TAP block will be performed under direct vision using 20 ml of 0.25% bupivacaine on each side after establishing pneumoperitoneum. The control group will undergo the same surgical procedure without the TAP block.

Read more

All patients will receive standardized anesthesia and postoperative pain management according to hospital protocol. Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS) at 0, 6, and 12 hours after surgery. Additional data, such as time to mobilization, use of rescue analgesics, and occurrence of postoperative complications (hematoma, swelling, subcutaneous emphysema, transient muscle weakness), will also be recorded.

The primary goal of this study is to determine whether a laparoscopically guided TAP block can effectively reduce postoperative pain and improve recovery parameters following TAPP hernia repair. The results may help establish a simple, safe, and reproducible method of multimodal analgesia in minimally invasive inguinal hernia surgery.

Read the detailed description

Inguinal hernia is one of the most common surgical conditions, affecting approximately 3% of the adult population. The only effective and lasting method of treatment is surgical repair. The laparoscopic transabdominal preperitoneal (TAPP) technique has become one of the most widely used minimally invasive approaches, offering reduced postoperative pain, shorter hospital stay, and faster return to daily activities compared with open repair. However, postoperative pain remains a relevant clinical problem and an important factor limiting early mobilization and recovery.

Multimodal analgesia is currently considered the standard approach for postoperative pain management. It combines systemic analgesics with regional anesthesia techniques. One of the increasingly used regional methods is the Transversus Abdominis Plane (TAP) block, which provides analgesia of the anterior abdominal wall by anesthetizing the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. The block can be performed under ultrasound guidance or, more recently, under direct laparoscopic vision, which improves safety and accuracy.

This single-center, prospective, randomized clinical study aims to assess the effect of a visually guided TAP block on postoperative pain and recovery after laparoscopic inguinal hernia repair (TAPP). The study will be conducted at the University Clinical Hospital in Olsztyn, Poland, between 2025 and 2027.

A total of 100 adult patients scheduled for elective laparoscopic TAPP hernia repair will be enrolled and randomly assigned (1:1) to one of two groups:

  1. TAP Block Group (n = 50): After pneumoperitoneum is established and the laparoscope is introduced, a bilateral TAP block will be performed under direct vision. Using a needle and syringe, 20 ml of 0.25% bupivacaine (50 mg) will be injected approximately 2 cm below the costal margin in the anterior axillary line on both sides. Proper distribution of the local anesthetic will be confirmed visually by observing the characteristic elevation of the transversus abdominis muscle layer (known as the "Doyle's bulge sign").
  2. Control Group (n = 50): The standard TAPP repair will be performed without additional regional anesthesia.

All patients will receive standardized general anesthesia and postoperative pain management. Analgesics will be administered according to a fixed schedule: metamizole 1.0 g orally at 6 and 12 hours after surgery. If needed, additional rescue medication will be provided: paracetamol 1.0 g orally for moderate pain (VAS < 6) or oxycodone 10 mg subcutaneously for severe pain (VAS > 6).

Pain intensity will be assessed using the Visual Analogue Scale (VAS) at 0, 6, and 12 hours after surgery, with separate evaluation for each surgical site (umbilical port, working trocar on the operated side, working trocar on the opposite side, operated groin, and operated testicle). Additional parameters include time to first mobilization, total analgesic consumption, and early postoperative recovery assessed with the Post Anesthesia Discharge Scoring System (PADSS). The occurrence of adverse events such as subcutaneous emphysema, hematoma, swelling, or transient lower limb weakness will also be recorded.

Patients with chronic pain syndromes, psychiatric disorders, alcohol or opioid dependence, recurrent hernias, or emergency indications will be excluded from the study. All participants will provide written informed consent before enrollment.

The collected data will be statistically analyzed to compare pain intensity, analgesic requirements, and recovery parameters between groups. The primary endpoint is postoperative pain intensity at 6 hours (VAS). Secondary endpoints include pain at 0 and 12 hours, time to mobilization, use of rescue analgesics, and adverse event rates.

The hypothesis of the study is that a laparoscopically guided TAP block significantly reduces postoperative pain intensity and improves recovery after laparoscopic TAPP hernia repair. The results of this study may contribute to the optimization of multimodal analgesia protocols in minimally invasive inguinal hernia surgery by introducing a simple, reproducible, and safe intraoperative analgesic technique.

Being tested
Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine
Keywords
Inguinal hernia, TAPP, Laparoscopic hernia repair, TAP block, Transversus abdominis plane block, Multimodal analgesia
Medical subject headings
Pain, Postoperative, Hernia, Inguinal

What participants receive

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

  • Laparoscopic Transversus Abdominis Plane (TAP) Block with BupivacaineProcedure or surgery

    Also called TAPP with TAP Block

    A bilateral Transversus Abdominis Plane (TAP) block is performed under direct laparoscopic vision after pneumoperitoneum is established. Using a needle and syringe, 20 ml of 0.25% bupivacaine is injected on each side, approximately 2 cm below the costal margin in the anterior axillary line. The correct spread of the local anesthetic is confirmed visually by observing the characteristic "Doyle's bulge sign." The procedure is performed before mesh placement during TAPP hernia repair. This technique allows direct visualization of the injection plane, increasing precision and safety compared with ultrasound-guided TAP blocks.

Study groups in NCT07264699
Study groupRoleWhat they receive
TAP Block Group (Laparoscopic TAP Block with Bupivacaine)ExperimentalAfter pneumoperitoneum is established and the laparoscope is introduced, a bilateral Transversus Abdominis Plane (TAP) block is performed under direct laparoscopic vision. Using a needle and syringe, 20 ml of 0.25% bupivacaine is injected on each side, approximately 2 cm below the costal margin in the anterior axillary line. The correct placement of the local anesthetic is confirmed by the visible "Doyle's bulge sign." Patients receive standard general anesthesia and postoperative pain management identical to the control group.
Receives: Procedure: Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine
Control Group (No Regional Anesthesia - Standard Care)No interventionParticipants undergo standard laparoscopic inguinal hernia repair using the transabdominal preperitoneal (TAPP) technique without performing a TAP block or any other regional anesthesia. All patients receive the same standardized general anesthesia protocol and postoperative analgesic regimen as those in the experimental group.

What is being measured

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

  1. Postoperative pain intensity (VAS score) at 6 hours after laparoscopic TAPP hernia repair

    Pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). The measurement will focus on the operated area 6 hours after the completion of laparoscopic TAPP hernia repair. Pain will be recorded by trained nursing staff according to a standardized protocol. Scores from both groups (TAP block vs. control) will be compared to evaluate the analgesic effectiveness of the visually guided TAP block.

    Measured: 6 hours postoperatively

Secondary outcomes (5)
  1. Postoperative pain intensity (VAS score) at 0 and 12 hours after surgery

    Pain will be evaluated using the VAS scale (0-10) at 0 (immediately after surgery) and 12 hours postoperatively.

    Measured: 0 and 12 hours after surgery

  2. Time to first mobilization

    The time (in hours) from the end of surgery to the patient's first ambulation will be recorded.

    Measured: Within 24 hours postoperatively

  3. Need for rescue analgesia

    Number of patients requiring additional analgesics (paracetamol or oxycodone) and total doses administered will be documented.

    Measured: First 12 hours after surgery

  4. Postoperative recovery score (PADSS)

    Recovery will be assessed using the Post Anesthesia Discharge Scoring System (PADSS). A score ≥9 will indicate readiness for discharge.

    Measured: 6 hours after surgery

  5. Incidence of postoperative complications

    Early postoperative complications such as hematoma, swelling, subcutaneous emphysema, or transient lower limb weakness will be recorded.

    Measured: Within 24 hours postoperatively

Timeline

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

  1. First posted4 Dec 2025
  2. Study start4 Dec 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (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
This is a prospective, randomized, parallel-group study comparing two interventions in patients undergoing elective laparoscopic inguinal hernia repair (TAPP). Participants will be randomly assigned in a 1:1 ratio to receive either a laparoscopically guided Transversus Abdominis Plane (TAP) block with 0.25% bupivacaine or no regional anesthesia. Both groups will receive identical perioperative care and standardized postoperative pain management. The design allows comparison of postoperative pain intensity and recovery outcomes between the TAP block and control groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07264699
Sponsor's protocol ID
UWM-TAP-TAPP-2025
Other IDs
19/2025/IX
Acronym
VIS-TAP-TAPP
Status last verified
Mar 2026
First submitted
23 Nov 2025
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because this is a single-center, investigator-initiated academic study involving a limited number of participants. The collected data include sensitive personal and clinical information that cannot be fully anonymized without compromising data integrity. Only aggregated, de-identified results will be published in peer-reviewed journals and conference presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine in people with Inguinal Hernia Repair and Postoperative Pain, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

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 5 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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 Poland. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Łukasz Dyśko, MD (+48895245341, lukaszdysko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity (VAS score) at 6 hours after laparoscopic TAPP hernia repair (time frame: 6 hours postoperatively). 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 17 Mar 2026.

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VIS-TAP-TAPP Clinical Trial NCT07264699 | AzTrials