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Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. When faced with this patient profile, there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs.
Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias. Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP-L | Experimental | After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25% |
|
| No ESP-L | No Intervention | Conventional intravenous analgesia after hip fracture surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Erector Spinae Plane Block. L bupivacaína 0.25% | Drug | Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25% |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery. | Collect data on post-surgery pain using the Visual Analogue Scale (VAS).The VAS scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain. | 2 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the analgesic postoperative needs after performing L-ESP block versus a control group of patients having undergone hip or proximal femur surgeries and the postoperative consumption of opioids in both groups | Consumption of morphine (mg) | 12 hours postoperative |
| Percentage of patients with technical ease to perform the esp-l block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura García Reza | Contact | 626708239 | laura.garcia.reza@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Laura García Reza | Hospital Álvaro Cunqueiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Álvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36312 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953436 | Derived | Garcia-Reza L, Raposeiras S, P Loureiro J, Pita-Romero R, Amate Pena JJ, Pereira Loureiro MA. Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2024 | Aug 14, 2024 |
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Pragmatic single-centre parallel group randomized clinical trial
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Pragmatic randomized low interventional single-centre parallel non blinded design with blinded assessment of the objectives.
We will define the technical ease of the esp-l block from 1 to 3. 1 being good and when we are able to clearly distinguish anatomical structures in order to carry out the locoregional analgesia, 2 would be equivalent to regular, when these are sensed but not clearly defined structures and bad when we are not able to distinguish any anatomical structure that allows us to carry out the block. |
| 48 hours postoperative |
| Patient satisfaction survey on pain management | We will classify patients into two groups according to their satisfaction with pain management in the postoperative period of hip surgery. Being the group of patients who consider themselves satisfied with pain management when it meets their expectations and dissatisfied if the patients are discomforted with it. | 48 hours postoperative |
| Describe de side effects of the lumbar ESP block and morphine | pruritus, nausea, vomiting, erythema, hypotension | 48 hours postoperative |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2024 | Aug 14, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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