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Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06778629
Acronym
TFPB
Enrollment
60
Registered
2025-01-16
Start date
2025-02-14
Completion date
2025-12-15
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Inguinal Hernia Repair, Acute Post Operative Pain

Keywords

Transversalis Fascia Plane Block, Acute Postoperative Pain, Laparoscopic Inguinal Hernia Repair

Brief summary

Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair. This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Detailed description

Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair. This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Interventions

After the wound closure is completed and the patient is still under general anesthesia the TFPB will be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed longitudinally, 2-3 cm laterally, just above the iliac crest at the mid-axillary line. After the external oblique, internal oblique, and transversus abdominis muscles are distinguished, the common aponeurosis of the transversus abdominis and the internal oblique muscle will be found. The block needle will be directed from anterior to posterior, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine, Polifarma ®) will be applied between the transversus abdominis muscle and transversalis fascia.

PROCEDUREPost Operative Pain Management

Acetaminophen 1 gr (Paracerol, Polifarma®) intravenous (IV), and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be administered to all patients 30 minutes before wound closure. After surgery, Acetaminophen (Paracerol, Polifarma®) 1 gr IV, and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be given three times a day. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV pethidine (Aldolan, Liba Laboratory ®) 0,5 mg/kg will be given as a rescue analgesic.

A total of 20 ml of 0.25% bupivacaine ( (Buvicaine, Polifarma ®) will be applied to the trocar entry points by the surgeon at the beginning of the operation, before entering the trocars.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The outcomes assessor and participants will be blinded to the study.

Intervention model description

Sixty patients aged 18-65 with American Society of Anesthesiologists (ASA) classification I-II scheduled for laparoscopic inguinal hernia repair operation will be included in the study. Before entering the operating room, patients will be randomly divided into two groups (Group T = TFPB group, Group K = control group), each with 30 patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) classification I- II Patients * Unilateral Inguinal Hernia Repair Surgery * Elective Operations

Exclusion criteria

* Patients with a history of chronic pain * Evidence of infection in the intervention area * Allergy to local anesthetics * Coagulopathy * Body-mass index (BMI) ≥ 30 * Body weight ≤ 50 kg * Patients who do not agree to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Rescue analgesic useNeed for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period

Secondary

MeasureTime frameDescription
Compare postoperative pain scores (NRS scores)NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.The secondary aim is to compare the pain scores at rest and with movement. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded. Low NRS is associated with better pain control.
Side effects and complicationsSide effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperativelyTo evaluate block-related complications and side effects (allergic reaction, nausea, vomiting)- block or opioid related

Countries

Turkey (Türkiye)

Contacts

Primary ContactAYSE INCE, Assist Prof
drayseince@gmail.com+90 5366774988
Backup ContactHANDE GUNGOR DANISAN, Assist Prof
drhandegungor@gmail.com+90 5053478392

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026