The Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Inguinal Lymph Node Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transversalis fascia plane block and surgical sit local anesthetic infiltration.
- Who it may be relevant to
- Registry conditions: Inguinal Lymph Nodes Enlarged. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Inguinal lymph node dissection (ILND) is the surgical removal of lymph nodes from the groin. Inguinal lymph node dissection is used to diagnose cancer spread from certain areas (usually penis, vulva, anus or the skin of the legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will recure in the future and help providers to determine the options for treatment. ( Pain accompanying ILND triggers a complex biochemical and physiological 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.
Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve . Several abdominal wall blocks are being used by anesthesiologists to provide postoperative analgesia for surgeries involving lower abdominal incisions. Transversus abdominis plane (TAP) block, quadratus lumborum block (QLB) and ilioinguinal-iliohypogastric block (IIIB). Transversalis fascia plane block (TFPB) was first described by Hebbard in the year 2009.
TFPB 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.
To our knowledge, there is no randomized controlled study about it until now in cancer patients undergoing inguinal lymph node dissection, so it will be one of the earliest studies that evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection.
Interventions
- Procedure transversalis fascia plane block and surgical sit local anesthetic infiltration
inguinal fascial plane block and surgical site local anesthetic infiltration
Primary outcome measures
- Pain scores using Visual analogue score [Time frame: 24 hours after the surgery]
Secondary outcome measures (5)
- Total intra-operative fentanyl consumption [Time frame: 2-3 hours (Surgery time) surgery]
- 1st time opioids requested post-operative. [Time frame: 24 hours after the surgery]
- Total post-operative morphine consumption. [Time frame: 24 hours after the surgery]
- Changes and stability in Mean Arterial Blood Pressure (MAP) [Time frame: 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) [Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- National Cancer Institute Cairo University — Cairo
Identifiers
NCT: NCT07331129 · AP2510-501-130-203