National Cancer Institute Cairo University
Cairo, 11796, Egypt
Location status: Recruiting
NCT Number: NCT07331129
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Cairo, 11796, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
inguinal fascial plane block and surgical site local anesthetic infiltration
Time frame: 24 hours after the surgery
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.
Time frame: 2-3 hours (Surgery time) surgery
the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Time frame: 24 hours after the surgery
In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.
Time frame: 24 hours after the surgery
The total 24-hour morphine consumption will be recorded for every patient post operative.
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Change in heart rate (HR) in beat\\min
Contact information is provided by the study sponsor or research team.
Asmaa Elsayed Khalil Elmoghazy, MD
CONTACT
01009468049 ext. 0020
Ayman Sharawy Abdel Rahman Aboul Nasr, MD
CONTACT
01282649008 ext. 0020
National Cancer Institute, Egypt
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.