Actively Recruiting
Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy
Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-09-24
60
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting patients
- Scheduled for laparoscopic hernia repair surgery
- ASA physical status I or II
- Aged between 18 and 65 years
- No history of anticoagulant or antiaggregant drug use
- Suitable for regional anesthesia as assessed by anesthesiologist
- Under general anesthesia undergoing laparoscopic surgery
- Fully oriented and cooperative
- Unilateral inguinal hernia
- No previous inguinal hernia surgery
- No incision in the lower abdomen
- Not using alcohol or drugs
- No preoperative pain
- No symptoms of strangulated hernia
You will not qualify if you...
- Patients who do not consent
- Contraindications to regional anesthesia
- Planned open abdominal surgery
- Outside the age range of 18 to 65 years
- Chronic diseases such as uncontrolled diabetes or hypertension
- Drug allergies
- Taking anticoagulant or antiaggregant drugs
- History of chronic analgesic use
- Active infection in the area to be blocked
- Unable to comply with postoperative pain or VAS follow-up
- ASA physical status III or IV
- Bilateral inguinal or scrotal hernias
- Previous inguinal hernia surgery or lower abdominal incision
- History of alcohol or drug abuse
- Preoperative pain
- Symptoms of strangulated hernia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Başakşehir Çam ve Sakura Şehir Hastanesi
Başakşehir, Istanbul, Turkey (Türkiye), 34480
Actively Recruiting
Research Team
A
Ali Bekraki, Principal Investigator
CONTACT
Y
Yunus Fırat Emekli, Research Assistant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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