Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block for Oncologic Thigh Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block for Oncologic Thigh Surgery: A Randomized Controlled Trial

Conditions
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Perioperative Pain

Intervention / Treatment
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* Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years. Physical status: ASA II,III Patient undergoing oncologic thigh surgery under general anesthesia. Body mass index (BMI): 20-40 kg/m 2 Exclusion Criteria: Patient refusal. Sensitivity or contraindication to local anesthetics. Bleeding tendency due to coagulopathy. Patients with opioid dependence or alcohol or drug abuse. Patients with psychiatric illness that prevent them from proper perception and assessment of pain. Contraindication to regional anesthesia e.g. local infection at the site of block, coagulopathy with INR more than 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities &amp; deficiency factor II) acquired (e.g. impaired liver functions with PC less than 60%, vitamin K deficiency &amp; therapeutic anticoagulant drugs) . Significant renal insufficiency (plasma creatinine more than 1.5 mg/dl).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprainguinal Fascia Iliaca Block group<br>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<br>* 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<br>|
| Experimental: Lumbar Erector Spinae Plane Block group<br>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<br>* 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<br>|
| No Intervention: control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morphine consumption . | Total postoperative morphine consumption over the first 24 hours postoperative. | over the first 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fentanyl consumption. | Total intra-operative fentanyl consumption. | intra-operative | 
| The time of first rescue analgesia. | The time of first rescue analgesia. | 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 | over the first 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suprainguinal Fascia Iliaca Block, Lumbar Erector Spinae Plane Block, postoperative pain