Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

NCT06778629 | Recruiting

• 1 other identifier: Medipol Hospital 5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Inguinal Hernia Repair; Acute Post Operative Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rescue analgesic use

  The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period

  Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.

Secondary Outcomes (2)

• 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.

• Side effects and complications

  Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively

Study Arms (2)

Group T = TFPB group

EXPERIMENTAL

Transversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied.

Procedure: Transversalis Fascia Plane Block; Procedure: Post Operative Pain Management; Procedure: Port Site Infiltration

Group K = Control group

ACTIVE COMPARATOR

Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. No plane block will be applied.

Procedure: Post Operative Pain Management; Procedure: Port Site Infiltration

Interventions

Transversalis Fascia Plane Block PROCEDURE

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.

Group T = TFPB group

Post Operative Pain Management PROCEDURE

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.

Group K = Control group; Group T = TFPB group

Port Site Infiltration PROCEDURE

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.

Group K = Control group; Group T = TFPB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bagcilar, 34212, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 38185619 RESULT

• 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.

  PMID: 39039833 RESULT

• 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.

  PMID: 19495909 RESULT

• 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.

  PMID: 37543778 RESULT

• 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.

  PMID: 22260427 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• BAHADIR CIFTCI

  ISTANBUL MUH

  STUDY CHAIR

Central Study Contacts

AYSE INCE, Assist Prof

CONTACT

+90 5366774988; drayseince@gmail.com

HANDE GUNGOR DANISAN, Assist Prof

CONTACT

+90 5053478392; drhandegungor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor and participants will be blinded to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: February 14, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)