The Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Inguinal Lymph Node Dissection

NCT07331129 | Recruiting DMC

• 1 other identifier: AP2510-501-130-203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pain accompanying Inguinal lymph node dissection triggers a complex stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction. Transversalis Fascia Plane Block is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.

Conditions

Inguinal Lymph Nodes Enlarged

Keywords

transversalis fascia plane block; ultrasound; inguinal lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Pain scores using Visual analogue score

  Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (0,1, 2, 4,6, 12 and 24h) postoperative.

  24 hours after the surgery

Secondary Outcomes (5)

• Total intra-operative fentanyl consumption

  2-3 hours (Surgery time) surgery

• 1st time opioids requested post-operative.

  24 hours after the surgery

• Total post-operative morphine consumption.

  24 hours after the surgery

• Changes and stability in Mean Arterial Blood Pressure (MAP)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

• Changes and stability in Heart Rate (HR)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

Study Arms (2)

ultrasound guided transversalis fascia plane block (TFPB).

ACTIVE COMPARATOR

Under aseptic precaution, TFPB will be performed under ultrasonographic guidance using a low-frequency convex transducer (Sonosite M turbo, USA). The patient will be placed in the lateral position. The probe will be introduced to orientation just above the iliac crest transversely; and the three abdominal muscle layers will be identified. Then the probe will be moved posteriorly to show the point at which the transversus abdominis muscle and the internal oblique muscle connected into a common fascia, which is just near the quadratus lumborum muscle. A 22-gauge 80-mm block needle will be used just to pierce the transversalis fascia. To confirm the correct needle tip placement, hydro-dissection will be performed using 2 mL of 0.9% saline following a negative check for blood aspiration to be safe from vascular puncture, then 20 ml of 0.25% bupivacaine will be injected. The real-time US scanning confirmed the spread of the LA in the target plane

Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltration

surgical incision site infiltration with the local anesthetics.

ACTIVE COMPARATOR

Patients of this group will receive local anesthetic 20 ml of 0.25% bupivacaine infiltration into the cutaneous and subcutaneous tissues at the surgical site.

Procedure: transversalis fascia plane block and surgical sit local anesthetic infiltration

Interventions

transversalis fascia plane block and surgical sit local anesthetic infiltration PROCEDURE

inguinal fascial plane block and surgical site local anesthetic infiltration

surgical incision site infiltration with the local anesthetics.; ultrasound guided transversalis fascia plane block (TFPB).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists (ASA) class I and II.
• Age ≥ 18 and ≤ 65 Years.
• Cancer patients for inguinal lymph node dissection.
• Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

You may not qualify if:

• Patient refusal.
• Local infection at the puncture site.
• Coagulopathies with platelets count below 50,000 or an INR\>1.6.
• Unstable cardiovascular disease.
• History of psychiatric and cognitive disorders.
• Patients allergic to medication used.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute Cairo University

Cairo, 11796, Egypt

RECRUITING

Study Officials

• Ayman Sharawy Abdel Rahman Aboul Nasr, MD

  National Cancer Institute Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Sharawy Abdel Rahman Aboul Nasr, MD

CONTACT

01282649008; ayman.sharawy@nci.cu.edu.eg

Asmaa Elsayed Khalil Elmoghazy, MD

CONTACT

01009468049; asmaakhalilmd2017@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

EG (1)