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

Phase 4

Recruiting

• Conditions: Analgesia
• Interventions: Drug: spinal anesthesia plane block; Drug: Lumbar Erector spinae plane block (L-ESPB); Drug: Fascia iliaca compartment block (FICB)

• Registration Number: NCT05905510
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2023-05-18
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-07
• Study Start: 2023-06-15
• Study First Posted: 2023-06-15
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	spinal anesthesia plane block	Patients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%).
Lumbar Erector spinae plane block (L-ESPB)	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.
Fascia iliaca compartment block (FICB)	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.

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative pain	UP to 24 hour postoperatively	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Elgharbia, Egypt