Clinical trial NCT06778629: Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair
Official title: Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Inguinal Hernia Repair
Acute Post Operative Pain
Keywords: Transversalis Fascia Plane Block
Acute Postoperative Pain
Laparoscopic Inguinal Hernia Repair
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rescue analgesic use
timeFrame: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.
Secondary outcomes:
measure: Compare postoperative pain scores (NRS scores)
timeFrame: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.
measure: Side effects and complications
timeFrame: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Mega Hospital Complex
state: Bagcilar
Study officials:
affiliation: ISTANBUL MUH
name: BAHADIR CIFTCI
role: STUDY_CHAIR
References:
citation: Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8.
citation: Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.
citation: Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
citation: Xu LS, Li Q, Wang Y, Wang JW, Wang S, Wu CW, Cao TT, Xia YB, Huang XX, Xu L. Current status and progress of laparoscopic inguinal hernia repair: A review. Medicine (Baltimore). 2023 Aug 4;102(31):e34554. doi: 10.1097/MD.0000000000034554.
citation: Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19.