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

Analgesia Clinical Trial

Official title:

Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905510
• Other study ID #: 35153/12/21
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: Tanta University
• Contact: Ahmed Ahmed Zahran, MBBCH
• Phone: +20 101 997 6377
• Email: ahmad162088[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• 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
• 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.
• spinal anesthesia plane block
Patients will receive spinal anesthesia alone

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time required for the first rescue analgesia.	Morphine sulfate 0.03 mg/kg will be administered intravenous as a rescue analgesic if Numeric rating scale is = 4	Up to 24 hours postoperatively
Secondary	The total postoperative rescue analgesic	The total amount of morphine consumption	first 24 hours postoperatively
Secondary	Adverse effects	Any complications or undesirable side effects will be observed and treated.	Up to 24 hours postoperatively