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

NCT ID: NCT05905510

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2023-12-01

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.

Detailed Description

Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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

Group Type: ACTIVE_COMPARATOR

spinal anesthesia plane block

Intervention Type: DRUG

Patients will receive spinal anesthesia alone

Lumbar Erector spinae plane block (L-ESPB)

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.

Group Type: ACTIVE_COMPARATOR

Lumbar Erector spinae plane block (L-ESPB)

Intervention Type: 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

Fascia iliaca compartment block (FICB)

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.

Group Type: ACTIVE_COMPARATOR

Fascia iliaca compartment block (FICB)

Intervention Type: 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.

Interventions

Lumbar Erector spinae plane block (L-ESPB)

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

Intervention Type: DRUG

Fascia iliaca compartment block (FICB)

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.

Intervention Type: DRUG

spinal anesthesia plane block

Patients will receive spinal anesthesia alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged 30-75 years from both sexes.

2. ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.

Exclusion Criteria

1. Patients' refusal.

2. Patients who were unable to co-operate with researchers.

3. History of allergy to local anesthetics.

4. Local infection at the site of the block.

5. Patients with bleeding and coagulation disorders.

6. Patients with renal, hepatic, cardiac decompensation, or spine deformities.

7. Patients receiving opioids for chronic analgesic therapy

8. Body mass index > 35 kg/m2

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ahmed Zahran

Doctor Ahmed Ahmed Eldemrdash Zahran Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine,Tanta University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, Elgharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Ahmed Zahran, MBBCH

Role: CONTACT

ahmad162088@med.tanta.edu.eg

+20 101 997 6377

Facility Contacts

Ahmed A Zahran, MBBCh

Role: primary

ahmad162088@med.tanta.edu.eg

+20 101 997 6377

Other Identifiers

35153/12/21

Identifier Type: -

Identifier Source: org_study_id