Visually Guided TAP Block in Laparoscopic TAPP Hernia Repair

NCT07264699 | Recruiting

• 2 other identifiers: UWM-TAP-TAPP-202519/2025/IX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Inguinal Hernia Repair; Postoperative Pain; TAP Block

Keywords

Inguinal hernia; TAPP; Laparoscopic hernia repair; TAP block; Transversus abdominis plane block; Multimodal analgesia

Outcome Measures

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.

  6 hours postoperatively

Secondary Outcomes (5)

• Postoperative pain intensity (VAS score) at 0 and 12 hours after surgery

  0 and 12 hours after surgery

• Time to first mobilization

  Within 24 hours postoperatively

• Need for rescue analgesia

  First 12 hours after surgery

• Postoperative recovery score (PADSS)

  6 hours after surgery

• Incidence of postoperative complications

  Within 24 hours postoperatively

Study Arms (2)

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.

Procedure: Laparoscopic Transversus Abdominis Plane (TAP) Block with Bupivacaine

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.

Interventions

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.

Also known as: TAPP with TAP Block

TAP Block Group (Laparoscopic TAP Block with Bupivacaine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Study Sites (1)

University Clinical Hospital in Olsztyn, Department of General and Oncological Surgery

Olsztyn, Warmisko-mazurskie, 10-041, Poland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Dental Occlusion; Bupivacaine; tetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marek Kowalczyk, PhD, MD

  Clinic of Oncological and General Surgery, University Clinical Hospital in Olsztyn, Olsztyn, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Łukasz Dyśko, MD

CONTACT

+48895245341; lukaszdysko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)