Visually Guided TAP Block in Laparoscopic TAPP Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Warmia and Mazury in Olsztyn
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recurrent or strangulated inguinal hernia
Emergency surgery
Chronic pain syndromes or preoperative opioid use
Known allergy or hypersensitivity to local anesthetics (bupivacaine or similar)
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine
Procedure/SurgeryA 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TAP Block Group (Laparoscopic TAP Block with Bupivacaine)Experimental treatment 1 intervention
Group B: Control Group (No Regional Anesthesia - Standard Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
6 hours postoperativelySecondary outcomes
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.
Time frame
0 and 12 hours after surgery2
Time to first mobilization
The time (in hours) from the end of surgery to the patient's first ambulation will be recorded.
Time frame
Within 24 hours postoperatively3
Need for rescue analgesia
Number of patients requiring additional analgesics (paracetamol or oxycodone) and total doses administered will be documented.
Time frame
First 12 hours after surgery4
Postoperative recovery score (PADSS)
Recovery will be assessed using the Post Anesthesia Discharge Scoring System (PADSS). A score ≥9 will indicate readiness for discharge.
Time frame
6 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov