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

Perioperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393726
• Other study ID #: AP2203-301-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: November 2023
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: December 15, 2024
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 & deficiency factor II) acquired (e.g. impaired liver functions with PC less than 60%, vitamin K deficiency & therapeutic anticoagulant drugs) .
• Significant renal insufficiency (plasma creatinine more than 1.5 mg/dl).

Related Conditions & MeSH terms

• Perioperative Pain

Intervention

Procedure:
• Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morphine consumption .	Total postoperative morphine consumption over the first 24 hours postoperative.	over the first 24 hours postoperative
Secondary	fentanyl consumption.	Total intra-operative fentanyl consumption.	intra-operative
Secondary	The time of first rescue analgesia.	The time of first rescue analgesia.	over the first 24 hours postoperative
Secondary	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