Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery
Phase: PHASE4
Conditions: Hip Fractures, Lumbar Erector Spinae Plane Block
Sponsor: Hospital Álvaro Cunqueiro

 
 
Comparative assessment of effectiveness 
and safety of Lumbar Erector Spinae Plane 
Block (L-ESPB) versus absence of 
locoregional block in hip surgery 
 
 
 
 
 
 
EU CT: 2024-511528-15-00 
05/0472024 
 
 
 
 
 
 
 
 
 

Comparative assessment of effectiveness and safety of Lumbar Erector Spinae Plane Block 
(L-ESPB) versus absence of locoregional block in hip surgery 
 
EU CT: 2024-511528-15-00 
 
Pragmatic single-centre parallel group randomized clinical trial. 
 
1. Introduction 
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 (1). 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 (2). 
The hip joint consists of the coxal bone (acetabulum) and the head of the femur, both lined by the 
hyaline cartilage. A protective and strong hip capsule seals the joint hermetically. Three strong 
ligaments (iliofemoral ligament, ligament of Bertin, or ischiofemoral ligament, and pubofemoral 
ligament) link the hip bones to the thigh. Its innervation is complex; it will depend essentially on the 
lumbar and lumbosacral plexuses. The anterior and more proximal region is that of the lumbar plexus 
(the major nerve of which is the femoral nerve) and the posterior face is innervated by the lumbosacral 
plexus (of which the major nerve is the sciatic nerve) (3). 
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 (4, 5). 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. 
 
2. Material and methods 
 
The clinical trial shall be carried out at the Hospital Universitario Álvaro Cunqueiro [Álvaro 
Cunqueiro Teaching Hospital] of Vigo. The recruitment period shall run from 1 July 2024 to 
December 2025. Patients recruited and included in the study shall previously sign a written informed 
consent. 
 
2.1 Inclusion and exclusion criteria 
 
This study shall include all patients of both sexes over 18 years of age having undergone hip surgery, 
ASA I-III (classification system used by the American Society of Anesthesiologists where I is low 
anesthetic risk and IV is high risk), with the capacity to comprehend the principles of pain assessment 
using the VAS visual analogue scale and having previously signed an informed consent. 
 
Exclusions shall apply to patients with contraindications for the technique and/or the drugs used in 
this context, in cases of technical inability to perform the block, to patients presenting with severe 
cognitive impairment or prior mental disabilities described in their medical records, or to patients 
already included in other clinical trials. 
 
2.2 Randomization 
 
Upon signing the informed consent and after the surgery, a systematic randomization shall be carried 
out by means of a computer system which shall define the arm to which a specific patient belongs. 

There will be two groups of patients (a group on which ultrasound-guided L-ESP shall be carried out 
at the L3-L4 level with 30 mL of levobupivacaine 0.25% and a control group which shall be handled 
with conventional intravenous analgesia). A total of 180 patients, 90 in each group, shall be 
randomized. 
 
Use of the locoregional technique renders it impossible to blind the study both to the patient and the 
anesthetist delivering it. Even so, a blind assessment of the objectives shall be carried out, as the 
nurses who will collect data from the first hours post-surgery and the unit staff nurses who will collect 
data in the subsequent hours will not know the group to which each patient belongs. 
 
2.3 Intervention 
 
It is a clinical trial designed and conducted by researchers in which the industry does not take part. It 
is included within a pragmatic randomized low interventional single-centre parallel non blinded 
design with blinded assessment of the objectives. All patients to undergo emergency or elective hip 
surgery who meet the inclusion criteria and do not meet any of the proposed exclusion criteria shall 
be included. The main variable shall be pain control (assessed with the VAS scale) after hip surgery. 
There will be two groups of patients (a group on which ultrasound-guided ESP-L shall be carried out 
at the L3-14 level with 30 mL of levobupivacaine 0.25% and a control group which shall be handled 
with conventional intravenous analgesia) (Appendix I). 
  
L-ESP block shall be carried out using a portable ultrasound machine with a linear or convex 
transducer, and a 50 mm or 80 mm Pajunk® 22G needle, depending on the target block depth. The 
patient shall be placed in the lateral decubitus position opposite to the leg to be blocked. We shall 
locate the transverse apophyses at the L3-L4 level with a parasagittal incision. Once this objective is 
located, a 22G 50 mm or 80 mm needle is inserted, depending on the depth of the same, from cranial 
to caudal in the plane of the ultrasound probe. We will advance through the erector spinae muscles, 
subsequently performing hydrodissection and injection of 30 mL of levobupivacaine 0.25% once 
negative aspiration has been carried out. 
 
In the group of patients without locoregional block, we will also collect data on post-surgery pain 
using the Visual Analogue Scale (VAS), use of opioids and complications associated with said use. 
 
We will collect the age, sex, height, weight, ASA, date of admission and date of surgery, type of 
surgery (prosthesis/osteosynthesis), type of anesthesia and pre-block VAS. 
 
When the locoregional technique is performed, the zero hour moment is deemed to be the time within 
the first two hours of the postoperative period when the patient presents with VAS >1. 
An analgesic postoperative protocol shall be available in which, after performing the locoregional 
technique (for the patients in that group), 1000 mg of paracetamol shall be administered every eight 
hours, as well as 50 mg of dexketoprofen or 400 mg of ibuprofen every eight hours. 1000 mg of 
metamizol every eight hours shall be prescribed for patients allergic to NSAIDs or paracetamol, or if 
needed for rescue. If VAS ≥4, 2 mg of morphine shall be concurrently prescribed. In the latter case, 
we shall reassess after 15 minutes. Should VAS ≥4 persist after delivery of the bolus, the same dose 
of morphine shall be repeated with subsequent assessment in 15 minutes, up to a maximum of 12 mg 
of morphine in twenty-four hours (see Appendix 2). 
We shall assess VAS at 30 minutes and 2, 6, 12, 24 and 48 hours, as well as the adverse effects of the 
locoregional block and the opioids; the degree of satisfaction of the patient and the technical ease of 
the block shall also be assessed. 
 
2.4 Objectives 
 

Primary objective 
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. 
 
Secondary objectives 
We shall 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; we shall assess and compare the technical ease of the surgery 
(L-ESP block) and the side effects in both lines of treatment. Finally, we shall assess the level of 
satisfaction of the patients. 
 
2.5 Statistical analysis 
 
The analysis shall be carried out using the IBM SPSS software platform. A descriptive analysis of all 
variables collected shall be carried out in which frequency and percentage shall be stated for 
categorical and mean variables, standard deviation and range for quantitative normal variables or 
mean and interquartile range for non-normal variables. Normality shall be assessed using the 
Kolmogorov-Smirnov test. 
Comparisons throughout monitoring of variables both of effectiveness and safety between both 
groups shall be analyzed with the Chi-square test for categorical variables and T-Student test for 
numerical variables, while for intragroup comparisons, the McNemar test shall be used for qualitative 
variables and the T-Student test for samples related to quantitative variables. If data from quantitative 
variables do not follow a normal distribution, the equivalent nonparametric Mann-Whitney U tests 
shall be used for independent groups and Wilcoxon tests for related samples. 
In all the hypothesis contrasts, statistically significant differences shall be deemed to exist when 
p<0,05. 
 
3. Discussion 
 
Hip fractures have major health, social and economic impact. This kind of fracture accounts for a 
high percentage of both urgent and elective surgeries in hospitals. Regardless of surgery being 
prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated 
comorbidities (1). 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 (6). Poor 
analgesic control of these patients results in a slower recovery with longer hospital stays, increased 
incidence of chronic pain and increased cardiovascular risks; hence the importance of a good 
management of said control (7). 
 
When dealing with a hip fracture, the conventional treatment shall be reduction and surgical fixation. 
In patients who are not candidates for surgery due to their high rate of comorbidities, pain control 
will be a challenge for healthcare professionals. Recent studies have even suggested using chemical 
denervation techniques to improve the quality of life in its final years. In countries such as Hong 
Kong, about 4% of these fractures are treated conservatively, as the patients are rejected for surgery 
(2).    
 
The Hospital Complex of Vigo, covering a healthcare area populated by 570,000 residents, has 
recorded 315 hip fractures in the last year. Average age of the patients was 85 years and 82% of them 
were women. 
In our center, regional anesthesia prevails significantly over general anesthesia for this kind of surgery. 
Both techniques have been found to be equally efficient, without major differences in morbimortality 

(8). Still, some revisions claim the superiority of regional anesthesia in these surgeries, with better 
postoperative results, and link general anesthesia to higher risk of hospital mortality, respiratory 
failure, longer average stays and higher rates of readmission (9). Ultrasound-guided regional 
anesthesia used in orthopedic and trauma surgery is on the rise, as it has been shown to reduce the 
doses of opioids and conventional analgesics (10, 11). 
Several peripheral blocks validated in hip surgery have been described in scientific literature. Among 
them are the fascia iliaca block, femoral nerve block, lateral femoral cutaneous nerve block, PENG 
block or the quadratus lumborum block, among others (12). 
 
The fascia iliaca block has been endorsed by multiple work groups, Mateusz Klukowski et al among 
them, who concluded that the patients on who this block was performed required less analgesic 
interventions (3 as opposed to 11, p<0.0001) and showed a significantly lower need for analgesics 
than patients without block, without complications after performance of said block (13). PENG block, 
used from 2018 and developed by Girón-Arango et al (14), is currently one of the peripheral nerve 
blocks most widely used in hip fracture patients. D-Yin Lin et al carried out a single-centre 
randomized double blind clinical trial which revealed that the patients on who PENG was performed 
for intraoperative and postoperative analgesia during hip fracture surgery experience less 
postoperative pain in the recovery room but there are no differences in the first postoperative day (15). 
 
Performance of this type of locoregional analgesia is not only useful for pain control after surgery, 
but it has even been successfully used prior to surgery. Ali Ishan Uysal et al confirm the effectiveness 
of the preoperative femoral nerve block in the trochanteric femur fracture surgery and in the 
prevention of pain during the application of regional anesthesia (16). 
Furthermore, given the many therapeutic analgesic options available for this kind of surgery, it is 
possible to compare them with each other so as to find the option that works best for each type of 
patient and surgical technique. There is an extensive comparative bibliography on this subject, such 
as the randomized clinical trial carried out by Faramarz Mosaffa, who concluded that PENG block is 
a good method for the analgesia of hip fractures and provides better analgesia than the fascia iliaca 
compartment block (17). 
 
L-ESP block consists in looking for the transverse apophyses at the L3-L4 level and depositing a local 
anesthetic at this level advancing through the erector spinae muscles to reach the apophyses. Diffusion 
of the local anesthetic varies depending on whether the block is performed at the thoracic or lumbar 
level due to the differences in the anatomy of each area; it has been found that at least 5 mL of local 
anesthetic would be necessary at the lumbar level versus 2.5 mL for the thoracic level (18). Some 
articles support the notion that the ESP block acts similarly to paravertebral blocks, as studies 
performed in cadavers have shown expansion of the local anesthetic at this level. The number of 
intercostal spaces that it may cover ranges between 7 and 3 (19). 
 
Lumbar parasagittal approach at L4 level in ultrasound-guided plane is the classic approach and it 
may be performed using anatomical landmarks (20). Serkan Turgal et al, among others, have reported 
extensive and lasting pain relief after a hip arthroscopy using single injection ESP at the L4 transverse 
apophysis level with bupivacaine 0.25% without significant motor block (21-23). Said publications 
are limited, as they are series of cases and not protocolized clinical trials. This block has even been 
used by Ali Ahiskalioglu as an intraoperative anesthetic technique together with sedation in an 
observational study with fifteen high-risk patients, performing a lumbar ESP block with 40 mL of a 
mix of local anesthetic (20 mL bupivacaine 0.5%, 10 mL lidocaine 2% and 10 mL of normal saline 
solution) together with propofol as a sedative; all surgeries were satisfactory, there being no need to 
change to general or intradural anesthesia (24). 
 
The option to combine this block is feasible and it has proven effective as described by Ince et al 
when combining the PENG block and the erector spinae plane block to provide treatment for 

postsurgery pain to a 4-year-old boy who underwent surgery to treat a congenital hip dysplasia, 
reducing the need for additional analgesics (25). 
 
Even the application of this block will allow us to compare it with others as Serkan Turgal et al did 
by means of a prospective study in which they conclude that both L-ESP  block and the quadratus 
lumborum block have a similar effect and both improve the quality of analgesia in patients who 
undergo hip and proximal femur surgery as against the standard intravenous analgesia regime (26). 
In spite of what has been described above, to this day there are very few clinical trials focusing on 
the L-ESP block applied to hip surgery and its comparison with conventional intravenous analgesia. 
 
4. Conclusions 
 
This pragmatic single-centre parallel group randomized clinical trial will allow us to assess the 
effectiveness of the L-ESP block in hip surgery. Additionally, we will also assess its safety and 
potential adverse effects as against conventional analgesia and consumption of opioids. Application 
of this kind of multimodal analgesia (associating locoregional blocks) will enable us to approach pain 
more comprehensively to achieve a faster rehabilitation and recovery of the hip surgery patient. 
 
5. Appendices 
 
 
Appendix 1. Timeline of the trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 2. Post-surgery analgesia protocol 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
6. Bibliography 
 
 
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hip fracture among nursing home residents. J Korean Med Sci. 2016;31(1):89–97. 
 
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for inoperable hip fracture. Anesth Analg. 2020;130(2):498–504. 
 
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