Clinical trial
Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty
Name
35153/12/21
Description
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.
Trial arms
Trial start
2023-06-15
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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
Arms:
Lumbar Erector spinae plane block (L-ESPB)
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.
Arms:
Fascia iliaca compartment block (FICB)
spinal anesthesia plane block
Patients will receive spinal anesthesia alone
Arms:
Control Group
Size
75
Primary endpoint
Assessment of postoperative pain
UP to 24 hour postoperatively
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-06-22
1 organization
3 products
1 indication
Organization
Tanta UniversityIndication
Analgesic