JMIR Publications

ABSTRACT

Background:

ABSTRACT

Background:

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; 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.

Methods:

A pragmatic single-centre parallel group randomized clinical trial. Upon signing the informed consent and after the surgery, a systematic randomization shall be carried out. There will be two groups of patients (a group on which ultrasound-guided L-ESP and a control group which shall be handled with conventional intravenous analgesia. A total of 180 patients, 90 in each group, shall be randomized. Our primary objetive is 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. Discussion: Because of the complex innervation of the hip joint, we believe that ESP-L block will be useful to manage pain in patients after 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. Dissemination plan: Study data will be disseminated to trial participants, the public, and academic communities.

Objective:

Primary outcome 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 outcome 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.

Methods:

A pragmatic single-centre parallel group randomized clinical trial. Upon signing the informed consent and after the surgery, a systematic randomization shall be carried out. There will be two groups of patients (a group on which ultrasound-guided L-ESP and a control group which shall be handled with conventional intravenous analgesia. A total of 180 patients, 90 in each group, shall be randomized. Our primary objetive is 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.

Results:

Patients from our health area who are to undergo scheduled or urgent hip and proximal femur surgery, meeting the inclusion criteria without any exclusion criteria, and who sign the informed consent.Considering a reduction of at least one point on the VAS scale, with an expected standard deviation of 2 and a statistical power of 90% and a type I error of 5%, a minimum of 86 patients per group was estimated. Therefore, a total n of 172 patients, to which 5% should be added for losses. The recruitment period will be 18 months. 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.

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. Clinical Trial: Clinical trial registration: ID: NCT06567522. EU CT 2024-511528-15-00 (ClinicalTrials.gov). Committee on Ethics for Drug Research in Galicia (CEIm-G): 24 May, 2024