An interventional study of Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block in Perioperative Pain, sponsored by National Cancer Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment
This is a prospective; double blinded randomized controlled trial that will be conducted on cancer patients subjected to oncologic thigh surgery.The aim of this study is to evaluate and compare the analgesic effect of supra-inguinal fascia iliaca block and lumbar erector spinae plane block in oncologic thigh surgery.Patients will be randomized into three equal comparable groups, Group A (Ultrasound-guided supra-inguinal fascia iliaca block (SIFIB)), Group B (Ultrasound-guided lumbar erector spinae plane block (L-ESPB)), and Group C (control group). Primary outcome parameter is the total postoperative morphine consumption over the first 24 hours postoperative. Data will be analyzed using IBM SPSS 26 (SPSS Inc., Chicago, IL).
Pain is one of the most common and significant postoperative events experienced by many surgical patients. Orthopedic surgery is a relatively painful surgery due to the significant amount of bone and soft tissue resection, damage, and reconstruction. After thigh surgery for sarcomas, the patient may experience any of three distinct types of pain, including acute postoperative pain, persistent long-term nociceptive pain, and neuropathic pain related to intraoperative nerve injuries. The management of pain in limb sparing surgery patients and amputated patients is crucial during the rehabilitation program and often its approach is multidisciplinary. The ultrasound-guided supra-inguinal fascia iliaca block further built on earlier anatomic discoveries to more reliably anesthetize the three nerves: femoral, lateral femoral cutaneous, and obturator. The supra-inguinal fascia iliaca block has evolved as an effective means of providing analgesia to the thigh, the knee, and, most notably, the hip. Ultrasound-guided erector spinae plane block (ESPB) is an interfascial plane block reported in the treatment of postoperative pain from surgical procedures, ranging from shoulder to hip surgery. When performed at the lumbar 4th vertebral level, ESPB led to sensorial blockage between Th12 and L4 dermatomes lead to effective postoperative analgesia in hip and proximal femoral surgery. Although supra-inguinal fascia iliaca block and L-ESPB successfully reduced postoperative opioid consumption in previous study, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing oncologic thigh surgery under general anesthesia. Thus, in this randomized comparative study we are aiming to fill this gape in the literature.
National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml.
Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block
Patients will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml.
Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block
Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia by using I.V. fentanyl (1µg/kg), with elevation of mean arterial blood pressure for more than 20% of their baseline values, additional bolus doses of fentanyl 0.5 µg /kg.
Suprainguinal Fascia Iliaca Block group will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. Lumbar Erector Spinae Plane Block group will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40 ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. control group will underwent surgery under general anesthesia and receive the perioperative routine protocol of analgesia
postoperative morphine consumption .
Total postoperative morphine consumption over the first 24 hours postoperative.
Time frame: over the first 24 hours postoperative
fentanyl consumption.
Total intra-operative fentanyl consumption.
Time frame: intra-operative
The time of first rescue analgesia.
The time of first rescue analgesia.
Time frame: over the first 24 hours postoperative
Visual Analogue Scale
Pain will be assessed using Visual Analogue Scale, both at rest and during movement, pain scores using visual Analogue Scale will be recorded in the post anesthesia care unit and for the next 24 hours postoperative.score (0) means no pain, scores(1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain
Time frame: over the first 24 hours postoperative
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute, Egypt