Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy

Summary

Laparoscopic inguinal hernia repair is a common surgical procedure, but postoperative pain management remains a challenge. This prospective, randomized study aims to compare the analgesic efficacy of preperitoneal and surgical site anesthetic infiltration with ultrasound-guided bilateral transversus abdominis plane (TAP) block in patients undergoing laparoscopic unilateral total extraperitoneal (TEP) herniorrhaphy. Sixty patients will be randomly allocated into two groups: Group-I will receive preperitoneal and surgical site infiltration with bupivacaine, while Group-II will receive ultrasound-guided bilateral TAP block with bupivacaine. The primary outcomes will be postoperative pain scores assessed using the visual analog scale (VAS) and additional analgesic requirements. Secondary outcomes will include postoperative hospital stay duration and cost-effectiveness. Demographic data, ASA scores, comorbidities, and operation times will be recorded. Postoperative pain will be managed with a multimodal approach, including paracetamol and NSAIDs. Rescue analgesia will be provided with intravenous paracetamol. Statistical analysis will be performed using t-tests, ANOVA, Wilcoxon-Mann-Whitney tests, and chi-square tests, as appropriate. This study aims to determine the optimal and most beneficial method for postoperative pain management and patient comfort following laparoscopic inguinal hernia repair.

Conditions

• Laparoscopic Surgery
• Herniorrhaphy
• Inguinal Hernia Unilateral
• Transversus Abdominis Plane (TAP) Block
• Postoperative Analgesia

Interventions

PROCEDURE

Surgeon-Initiated Local Anesthetic

In laparoscopic hernia repairs, patients are positioned supine, and the surgical area is cleansed with povidone iodine and covered with sterile green drapes. A 1-centimeter incision will be made 1 centimeter below the umbilical border. A 10-mm trocar will be inserted into the preperitoneal space. The operation was filmed from the front with a 30-degree camera. After observing the preperitoneal space, two five-mm working trocars will be placed midline, two and six centimeters inferior to the symphysis pubis. Next, the cord structures and Cooper ligament will be exposed and the hernia sac freed from surrounding anatomical structures.Prolene mesh will be spread over the preperitoneal area to cover all hernia defects and secured to the Cooper ligament and abdominal wall with an absorbable fixation device. Group 1 patients undergo desufflation via 50 mg of bupivacaine into the preperitoneal space, followed by 10 mg of bupivacaine into each trocar incision and skin closure with sutures.

PROCEDURE

Transversus abdominis plane (TAP) block

After the surgery, the anesthesiologist will use a TAP block under ultrasound guidance. Before the patient wakes up, the Hitachi ultrasound probe will be sterilized and positioned between the iliac wing and the costae. An ultrasound shows the skin, fat beneath it, the six abdominal muscle layers, and a support muscle.A thin needle goes through the skin from one side to the other to reach the muscle layers. The location of the block is confirmed by injecting 1-2 ml of 0.09% NaCl followed by negative aspiration. Patients receive 15-20 ml (40-50 mg per quadrant) of bupivacaine 0.5% concentration in a controlled manner with negative aspiration every 5 ml. The block is performed bilaterally.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital

  lead OTHER_GOV

Principal Investigators

• EMINE OZCAN, MD · Başakşehir Çam ve Sakura Şehir Hastanesi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-04

Primary Completion

2026-06-20

Completion

2026-06-30

Countries

• Turkey (Türkiye)

Study Locations