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| ID | Type | Description | Link |
|---|---|---|---|
| 19/2025/IX | Other Identifier | Ethics Committee Approval Number - Warmian-Masurian Chamber of Physicians in Olsztyn |
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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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block Group (Laparoscopic TAP Block with Bupivacaine) | Experimental | After 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. |
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| Control Group (No Regional Anesthesia - Standard Care) | No Intervention | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 12 hours after surgery |
| Time to first mobilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Łukasz Dyśko, MD | Contact | +48895245341 | lukaszdysko@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marek Kowalczyk, PhD, MD | Clinic of Oncological and General Surgery, University Clinical Hospital in Olsztyn, Olsztyn, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital in Olsztyn, Department of General and Oncological Surgery | Recruiting | Olsztyn | Warmisko-mazurskie | 10-041 | Poland |
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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| D002045 | Bupivacaine |
| C034807 | tetra-4-amidinophenoxypropane |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
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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.
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This study uses a single-blind design. Randomization is performed immediately before surgery using a concealed allocation sequence. The operating surgeons are aware of group assignment in order to perform the appropriate intervention (TAP block or none). Participants remain blinded to their allocation throughout the study period. Postoperative data, including pain intensity (VAS) and recovery parameters, are collected according to a standardized protocol by staff not involved in the randomization or intervention process to reduce potential bias.
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The time (in hours) from the end of surgery to the patient's first ambulation will be recorded.
| Within 24 hours postoperatively |
| Need for rescue analgesia | Number of patients requiring additional analgesics (paracetamol or oxycodone) and total doses administered will be documented. | First 12 hours after surgery |
| Postoperative recovery score (PADSS) | Recovery will be assessed using the Post Anesthesia Discharge Scoring System (PADSS). A score ≥9 will indicate readiness for discharge. | 6 hours after surgery |
| Incidence of postoperative complications | Early postoperative complications such as hematoma, swelling, subcutaneous emphysema, or transient lower limb weakness will be recorded. | Within 24 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |