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

NCT05393726 | Completed

• 1 other identifier: 2203-301-014
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Perioperative Pain

Keywords

Suprainguinal Fascia Iliaca Block; Lumbar Erector Spinae Plane Block; postoperative pain

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption .

  Total postoperative morphine consumption over the first 24 hours postoperative.

  over the first 24 hours postoperative

Secondary Outcomes (3)

• fentanyl consumption.

  intra-operative

• The time of first rescue analgesia.

  over the first 24 hours postoperative

• Visual Analogue Scale

  over the first 24 hours postoperative

Study Arms (3)

Suprainguinal Fascia Iliaca Block group

EXPERIMENTAL

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

Lumbar Erector Spinae Plane Block group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block PROCEDURE

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

Lumbar Erector Spinae Plane Block group; Suprainguinal Fascia Iliaca Block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 26, 2022
• Study Start: June 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

EG (1)