Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block After Total Hip Arthroplasty

NCT05905510 | Unknown Phase 4

• 1 other identifier: 35153/12/21
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain

  Assessment of postoperative pain using the Numeric rating scale (NRS), NRS is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain)

  UP to 24 hour postoperatively

Secondary Outcomes (3)

• Time required for the first rescue analgesia.

  Up to 24 hours postoperatively

• The total postoperative rescue analgesic

  first 24 hours postoperatively

• Adverse effects

  Up to 24 hours postoperatively

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%).

Drug: spinal anesthesia plane block

Lumbar Erector spinae plane block (L-ESPB)

ACTIVE COMPARATOR

Patients will receive spinal anesthesia and then ipsilateral lumbar erector spinae plane block (30 ml bupivacaine 0. 25%) at the level of the lumbar region in the operating room after the end of the surgery.

Drug: Lumbar Erector spinae plane block (L-ESPB)

Fascia iliaca compartment block (FICB)

ACTIVE COMPARATOR

Patients will receive spinal anesthesia and then ipsilateral suprainguinal fascia iliaca compartment block (30 ml bupivacaine 0. 25%) in the operating room after the end of the surgery.

Drug: Fascia iliaca compartment block (FICB)

Interventions

Lumbar Erector spinae plane block (L-ESPB) DRUG

The fourth lumbar vertebral level will be determined using the conventional method (the imaginary line between two crista iliacas). The convex transducer will be placed at the mid-vertebral line in the sagittal plane. The transducer will be shifted from the midline, 3.5-4 cm laterally, to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-of-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthesia solution (30 ml bupivacaine 0.25%) will be administered, leading to hydro dissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when administering local anesthesia. All local anesthesia will be administered to this location between the transverse process and the erector spinae muscle

Lumbar Erector spinae plane block (L-ESPB)

Fascia iliaca compartment block (FICB) DRUG

The transducer will be placed laterally to the femoral nerve. It then rotated 90 degrees to the sagittal plane, under ultrasound guidance, a regional block needle (22 G, 80 mm) will be introduced in the cranial direction. Once good needle alignment with the ultrasound beam is achieved, the needle will be inserted deep into the tissues until an optimal position of the needle tip is obtained. Needle location will be additionally verified by injecting 0.5-1 ml of the prepared local anesthesia solution and observing the solution spread within the tissues. Once the correct position of the needle tip is confirmed, the local anesthetic will be deposited under the iliac fascia to force its flow towards the lumbar plexus. 30 ml of bupivacaine 0.25% solution will be used for the block. local anesthesia will be administered as 5 mL boluses with a 20 second interval.

Fascia iliaca compartment block (FICB)

spinal anesthesia plane block DRUG

Patients will receive spinal anesthesia alone

Control Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 30-75 years from both sexes.
• ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.

You may not qualify if:

• Patients' refusal.
• Patients who were unable to co-operate with researchers.
• History of allergy to local anesthetics.
• Local infection at the site of the block.
• Patients with bleeding and coagulation disorders.
• Patients with renal, hepatic, cardiac decompensation, or spine deformities.
• Patients receiving opioids for chronic analgesic therapy
• Body mass index \> 35 kg/m2

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Ahmed Zahran, MBBCH

CONTACT

+20 101 997 6377; ahmad162088@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Ahmed Ahmed Eldemrdash Zahran Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine,Tanta University

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From one year after study completion
• Access Criteria: The data will be available upon reasonable request from the corresponding author.

Locations

EG (1)