NCT06894420 Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy
| NCT ID | NCT06894420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Başakşehir Çam & Sakura City Hospital |
| Condition | Laparoscopic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-04 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Consenting patients, * She will undergo laparoscopic hernia repair surgery, * ASA-I-II, * Between the ages of 18 and 65, * No history of anticoagulant or antiaggregant drug use, * Regional anesthesia is not contraindicated and the anesthesiologist deems -appropriate for regional anesthesia, * Under general anesthesia and will undergo laparoscopic surgery, * Fully oriented and cooperative, * Unilateral inguinal hernia, * No previous surgery for inguinal hernia, * No incision in the lower abdomen, * Not using alcohol and drugs, * No preoperative pain and * Patients without symptoms of strangulated hernia will be included in the study. Exclusion Criteria: * Patients without consent * Regional anesthesia is contraindicated, * Those who will undergo open abdominal surgery, * Not in the appropriate age range, * Chronic diseases such as uncontrolled DM and HT, * Drug allergy, * Taking anticoagulant or antiaggregant drugs, * History of chronic analgesic use, * Presence of active infection in the area to be blocked, * Will not be able to comply with postoperative pain /VAS follow-up, * Patients with ASA-III-IV, * Patients with bilateral inguinal and scrotal hernias, * Patients who have been previously operated for inguinal hernia and have an incision in the lower abdomen, * Those with a history of alcohol and drug abuse * Preoperative pain and * Those with symptoms of strangulated hernia will not be included in this study.
Contact & Investigator
EMINE OZCAN, MD
STUDY DIRECTOR
Başakşehir Çam ve Sakura Şehir Hastanesi
Frequently Asked Questions
Who can join the NCT06894420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Laparoscopic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894420 currently recruiting?
Yes, NCT06894420 is actively recruiting participants. Contact the research team at abekraki@hotmail.com for enrollment information.
Where is the NCT06894420 trial being conducted?
This trial is being conducted at Başakşehir, Turkey (Türkiye).
Who is sponsoring the NCT06894420 clinical trial?
NCT06894420 is sponsored by Başakşehir Çam & Sakura City Hospital. The principal investigator is EMINE OZCAN, MD at Başakşehir Çam ve Sakura Şehir Hastanesi. The trial plans to enroll 60 participants.