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Evaluation of Peri-operative Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Cancer Patients Undergoing Inguinal Lymph Node Dissection: A Prospective Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Egypt
National Cancer Institute Cairo University
RECRUITING
Cairo
Contact Information
Primary
Ayman Sharawy Abdel Rahman Aboul Nasr, MD
ayman.sharawy@nci.cu.edu.eg
01282649008
Backup
Asmaa Elsayed Khalil Elmoghazy, MD
asmaakhalilmd2017@gmail.com
01009468049
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2026-06-29
Participants
Target number of participants: 90
Treatments
Active_comparator: ultrasound guided transversalis fascia plane block (TFPB).
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
Active_comparator: surgical incision site infiltration with the local anesthetics.
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.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute, Egypt

This content was sourced from clinicaltrials.gov