Keywords
arthroplasty, replacement, hip - arthroplasty, replacement, knee - clinical protocols
Introduction
In Brazil, there is a projection that in 2030, people over 60 years old who have a
higher incidence of hip and knee osteoarthritis will be 19% of the Brazilian population
or 42,122,847 people.[1]
The growth of the elderly population also has consequences for the number of hip and
knee arthroplasty surgeries performed in the SUS (Public Health System), in which
there is an average annual increase of 3.3% and 8.7% respectively,[2] with 15,042 hospitalizations for hip arthroplasty in 2019, pre-pandemic due to COVID
19 according to the DataSus website.
Rapid Recovery Protocols originally come from Enhanced Recovery After Surgery (ERAS)
or Fast Track Protocol (FTP) which was developed in the late 1990's by Dr. Henrik
Kehlet as a strategy to reduce the length of hospital stay after major surgeries,
but only from 2005 allowed a better recovery not only in quantitative terms, but also
in qualitative terms.[3]
[4] According to the ERAS Society, the organization that initiated studies on FTP's
for abdominal surgeries, there are about 20 precautions that influence the response
to surgical stress and increase the patient's recovery speed after the procedure.
Thus, an FTP team must include professionals who are engaged and experienced in surgery,
anesthesia, nursing, physiotherapy, and nutrition. The team has primary responsibility
for reviewing the available literature and formulating and delivering the appropriate
protocol for their institution.[5] The implementation of the FTP in any hospital depends on the interaction and coordinated
work of the multidisciplinary teams that are the pillars for the success of this journey
of implementation and maintenance of the active protocol.
Taking into account that the Brazilian socioeconomic reality is that of a developing
country and that the health system in Brazil is mostly represented by the SUS, which
faces great financial difficulties and scarce resources, we adapted a FTP model to
the reality of Brazilian public hospitals for elective total hip arthroplasty surgery
performed in a public hospital in São Paulo - Brazil.
Methodology
This work is a clinical research protocol that was conducted in compliance with all
stipulations of this protocol, current national regulations, and guidelines established
by the Document of the Americas and the ICH Guide to Good Clinical Practice. And it
was approved by the Research Ethics Committee, under number CAAE: 30064919.6.0000.0068.
A prospective study carried out on 98 patients selected to electively undergo total
hip arthroplasty surgery by anterolateral approach (AA), posterior approach (PA) and
direct anterior approach (DAA), from December 2018 to March 2020.
Patients included with a diagnosis of hip osteoarthritis and/or necrosis of the femoral
head (Ficat III or IV) and who agreed to sign the Informed Consent Form were eligible.
Exclusion criteria: Crowe's dysplasia type 3 or 4; previous hip surgery; clinical
inability or reluctance to participate in the study.
Implementation Program
After performing the preoperative exams, the patients were referred for a preoperative
consultation with the anesthesiologist for clinical evaluation and ASA classification.[6] If complementary exams or evaluations from other specialties were necessary, the
patient was referred to the specialist, returning with the anesthesiologist for a
final evaluation.
Once eligible for the surgery, the nursing team advised the hospitalization, explained
details of the surgery and delivered an informative booklet with illustrations of
the surgical procedure with the steps to be followed in the preoperative, intraoperative
and postoperative periods. It was also explained to the patient that they would be
discharged from the hospital as soon as their clinical condition was stable and safe
according to established clinical parameters.
At that moment, the nutritionist guided the patient regarding pre-surgical caloric
and nutritional intake, so that they could be hospitalized on the day of surgery in
a favorable metabolic state, explaining the need to fast for 8 hours preoperatively
and the supplemented abbreviated fasting methodology with maltodextrin 3 hours before
surgery.
The patient was assessed by the physiotherapy team, with preoperative functional assessment
scores. They guided the patient about strengthening exercises to be performed before
surgery, so that the patient could maintain or even gain muscle mass in the hip and
knee extensors, facilitating postoperative physical rehabilitation.
The criterion for choosing the surgical approach was based on the surgeon's experience.
Each physician standardized the use of only one access route to the hip to be performed
in all of their patients and the randomization occurred due to the random criterion
for scheduling pre-surgical outpatient consultations with the surgeons.
Preferential anesthesia was spinal anesthesia without the use of morphine supplemented
with pericapsular and periacetabular infiltration performed at the end of the procedure
by the surgeon with 1ml per kilogram of the following solution: 70ml of Saline Sodium
Chloride 0.9%, 30 ml of Ropivacaine 7.5mg/ml, 1 ml of Adrenaline 1mg/ml and 1 ml of
Clonidine 150mcg/ml. If the patient had contraindication for spinal anesthesia, general
anesthesia was performed.
The use of infusion of blood products was carefully evaluated, taking into account
the surgeon's perception of blood loss during the surgical procedure, the calculation
of the loss of aspirated fluids and the clinical conditions that were monitored by
the anesthesiologist.
Postoperative referral to the ICU was restricted only to patients who presented hemodynamic
instability, need for infusion of blood products or changes in cardiological monitoring
during surgery.
The perception of pain during post-anesthetic recovery was assessed by the anesthetic
team. Simple analgesics or anti-inflammatory drugs were prescribed and opioids were
left only as a rescue option.
The patient was received from Post-Anesthetic Recovery, evaluated by the nursing team
and the nutritionist prescribed the diet, avoiding prolonged fasting.
The physiotherapy team evaluated the patient and advised them on the need for early
walking to avoid postoperative comorbidities such as DVT.
DVT prophylaxis was established with Enoxaparin Sodium 40mg subcutaneously once a
day during the hospitalization period in the ward.
The surgeons held medical consultations together with the physiotherapist to provide
support and initial gait guidelines on the same day or the day after the surgery.
The criteria for starting gait were the patient's ability to sit up in bed, be able
to transfer alone with the aid of the walker to the chair, stand up with the support
of the walker without pain.
If a postoperative drain was used, it was preferably removed within 24 hours.
Hospital discharge guidelines were provided by the multidisciplinary team, emphasizing
the following aspects: Encouraging the patient, family member and/or caregiver to
talk about their concerns with home care, continuing rehabilitation at home with an
emphasis on post-surgical restrictions such as not bending the hip more than 90 degrees,
not crossing the operated leg over the other, not internally rotating the foot on
the operated side.
Patients were released for hospital discharge if they met the following criteria:
being pain-free, walking alone with or without the use of a walker, being able to
sit up in bed alone, having spontaneously defecated and urinated, the dressing of
the surgical incision had to be dry and clean, normal blood pressure, heart rate and
temperature parameters.
Simple analgesics were prescribed for home, such as Dipyrone 1g every 6h if pain and
Paracetamol 750mg every 6h if pain and if there was moderate or severe pain, Tramadol
50mg every 6h if pain was moderate or severe. DVT prophylaxis with Acetyl Salicylic
Acid (ASA) 100mg orally for 30 days was also prescribed.
Evaluations regarding postoperative complications covered the immediate postoperative
period up to 3 months of outpatient follow-up.
Weekly meetings between members of the multidisciplinary team were held with the intention
of standardizing information and distributing tasks to be carried out in order to
adapt FTP concepts to the Brazilian reality.
During the meetings for the FTP to be implemented, questions were discussed together,
establishing a goal of actions to be fulfilled. The personal engagement of each professional
was essential for these actions to be implemented, since the communication of these
new concepts to the respective professionals of each specialty involved was the responsibility
of the professional participating in the FTP Implementation Group ([Fig. 1]).
Fig. 1 Pre, intra, and postoperative care for FTP implantation. (Adapted from Soffin EM,
YaDeau JT. Enhanced recovery after surgery for primary hip and knee arthroplasty:
a review of the evidence. Br J Anaesth. 2016 Dec;117).
Statistical analysis
Descriptive analyzes were carried out where the quantitative data that presented normal
distribution were presented with means accompanied by the respective standard deviations.
Data that did not show normal distribution were presented with medians and IQ interquartile
ranges (25%-75%). Categorical variables were presented with frequency and percentage.
The normal distribution in each group and the homogeneity of the variances between
the groups were evaluated, respectively, with the Shapiro-Wilk test and the Levene
test.
The Wilcoxon test for a sample and the Kruskal Wallis test were used for the analysis
of numerical variables for multiple comparisons, the Dunn test was used.
To compare proportions, the chi-square or Fisher's exact test was used when necessary.
A statistical significance value less than or equal to 5% (p ≤ 0.05) was used for
all analyzes.
Statistical modeling and tests were performed using SPSS software version 21.0.
Results
All data from the study of 98 patients who underwent total hip arthroplasty from December
2018 to March 2020 were recorded in medical records and had a mean age of 62.8 years
(34 to 81), 56 men and 43 women divided into the following age groups shown in [Fig. 2]. 94 patients (95%) were operated on for primary osteoarthritis and 4 for osteoarthritis
secondary to other pathologies, with the following associated comorbidities ([Fig. 3]).
Fig. 2 Age group of sample patients.
Fig. 3 Incidence of comorbidities in the studied population. CID – Contagious Infectious
Disease, CVD – Cardiovascular Disease, SAH – Systemic Arterial Hypertension, DM2–Type
2 Diabetes Mellitus.
Of the 98 patients, 54 were operated on through AA access, 35 through the DAA and
9 through the PA.
In the studied population, we had 14 (14.29%) of the patients classified as ASA1;
71 (72.45%) of the patients classified as ASA 2 and 13 (13.27%) of the patients classified
as ASA 3 as shown in [Fig. 4].
Fig. 4 Distribution of patients according to the ASA classification of the American Society
of Anesthesiology.
The average length of hospital stay was 2.8 days ([Fig. 4]) with 3 (3.06%) patients staying 1 day, 45 (45.92%) staying 2 days, 30 (30.61%)
staying 3 days, 15 (15.41%) staying 4 days, 2 (2.04%) 5 days, 2 (2.04%) 6 days and
1 (1.02%) staying 12 days according to [Fig. 5].
Fig. 5 Hospital stay: 3 patients stayed 1 day, 45 patients stayed 2 days, 30 patients stayed
3 days, 15 patients stayed 4 days, 2 patients stayed 5 days, 2 patients stayed 6 days
and 1 patient 12 days.
The average length of hospital stay for DAA was 2.1 days, 3 days for AA and 4.11 days
for PA as seen in [Fig. 6].
Fig. 6 Length of hospital stay of 2.1 days for the anterior approach, 3.0 days for the anterolateral
approach and 4.11 days for the posterior approach.
The average surgery time was 90 minutes, 4 (4%) patients required transfusion of blood
products, 19 (19%) of the patients were referred to the ICU in the postoperative period,
with 14 (76%) remaining 1 day and 5 ( 26%) 2 days.
Of the 35 patients operated by DAA, none went to the ICU in the postoperative period,
while 19 (30.15%) operated by other means went to the ICU, as shown in [Fig. 7].
Fig. 7 No patient operated via the anterior approach went to the ICU postoperatively. 30.15%
of patients operated on by other approaches went to the ICU and 69.85% were not.
Of the total sample of 98 patients, 4 (4.08%) required transfusion of blood products
during the surgical procedure, 1 (1.02%) operated through DAA and 3 (3.06%) through
AA. There were no patients who received transfusions after the end of the surgical
procedure, as shown in [Fig. 8] below.
Fig. 8 Of the total sample of 98 patients, 4 (4.08%) received transfusion of blood products,
1 (1.02%) operated through the anterior approach and 3 (3.06%) through the lateral
approach.
During the hospitalization period, the stimulus for early walking was followed according
to the methodology and all patients were discharged walking with the help of a walker.
As for immediate postoperative complications during the hospitalization period, we
had no cases of deep vein thrombosis (DVT), pulmonary embolism (PTE) or neurological
injury, 19 (19.39%) patients had postoperative bleeding requiring replacement of dressing,
4 (4.08%) needed blood transfusion, 2 (2.04%) patients had implant instability verified
during hospitalization, 1 by anterolateral approach and 1 by a posterior approach,
and were treated conservatively, 1 (1.02%) patient had a fracture during surgery,
with femur cerclage being performed, and 1 (1.02%) patient died of cardiac complications,
as shown in [Fig. 9].
Fig. 9 Total sample 98 patients, 19 (19.39%) of the patients had bleeding in the immediate
postoperative period, 4 (4.08%) required transfusion of blood products, 2 (2.04%)
had implant instability, 1 ( 1.02%) had a femur fracture, 1 (1.02%) died. There were
no cases of Deep Vein Thrombosis (DVT), Pulmonary Thromboembolism (PTE) or Peripheral
Nerve Injury.
In the postoperative follow-up of up to 3 months, we had the following complications:
2 (2.04%) patients had a superficial infection in the access route treated with oral
antibiotic therapy, 1 (1.02%) patient had a femur fracture without deviation due to
a fall from own height 2 months after the initial surgical procedure and was treated
conservatively and 1 (1.02%) patient had DVT diagnosed in the operated limb 15 days
after the surgical procedure, however it was found that the patient did not take the
prophylaxis recommended as can be seen in [Fig. 10].
Fig. 10 Postoperative complications within 3 months. We had 2 (2.04%) cases of superficial
infection of the surgical wound, 1 (1.02%) of femur fractures and 1 (1.02%) case of
DVT.
Discussion
Our overall length of hospital stay (LHS) was 2.8 days, 2.1 days for the anterior
route, 3.0 days for the anterolateral route, and 4.1 days for the posterior route.
According to Marcio de Castro Ferreira, in his article “Total knee and hip arthroplasty:
The worrying reality of care in the Brazilian Unified Health System”, the national
average length of hospital stay for elective total hip arthroplasty is 7.1 days[2] ([Fig. 11]).
Fig. 11 The length of stay for all patients in the sample was 2.8 days and the national average
is 7.1 days (p < 0.001).
Overall, there is little evidence to support the use of structured preoperative education
to reduce postoperative adverse events, improve pain, facilitate functional recovery,
or reduce length of stay. However, a significant reduction in preoperative anxiety
can be achieved. Preoperative education may benefit more patients with depression,
anxiety, unrealistic expectations or limited social support.[7]
[8]
[9]
Decreased length of stay is consistently associated with the use of neuraxial anesthesia
(anesthetic block) compared with the use of general anesthesia. In a multicenter retrospective
study associating the use of general anesthesia with an 8.5-fold increased risk of
moderate to severe postoperative pain and a 2.5-fold increased risk of persistent
postoperative pain, for hip arthroplasty and knee.[10]
[11] These data provide additional motivation for the use of neuraxial anesthesia or
plexus block.
Non-opioid spinal anesthesia supplemented with local infiltration analgesia (LIA)
is a recent technique for early postoperative analgesia after knee and hip arthroplasty,
and was administered by surgeons shortly after completion of the surgical procedure,
providing 6–12 hours of pain relief so patients benefit from multimodal analgesia
and oral opioids only if needed.[12]
[13]
Our results with a total sample of 98 patients showed that 19 (19.39%) had bleeding
in the immediate postoperative period with the need to change the surgical dressing,
4 (4.08%) required transfusion of blood products, 2 (2 .04%) had implant instability
with signs of subluxation of the prosthesis, one patient operated via an anterolateral
approach and one patient operated via a posterior approach, both of which were treated
conservatively and followed up on an outpatient basis, 1 (1.02%) had a fracture of
the femur during the surgical procedure, fixation with cerclage using steel wires
was performed, 1 (1.02%) died of cardiac complications.
The results obtained corroborate Starks et al. who applied the FTP in patients undergoing
total hip or knee arthroplasty, observed that the mortality rate for total knee arthroplasty
decreased from 0.44 to 0.07%. Starks' work can be seen as an early model for FTP in
orthopedic surgery.[5]
Nutritional guidelines now allow fluid intake up to 3 hours before induction of anesthesia
and 6-hour fasting for solid food. In addition to the reduced fasting time, the FTP
recommends that patients consume up to 300 ml of a clear carbohydrate-rich drink 3 hours
before surgery, with the aim of presenting the patient for surgery in a metabolically
“fed” state, avoiding catabolism.[14]
[15]
[16]
[17]
In our sample, we did not have any DVT or PTE events during the hospitalization period.
Early mobilization is a key component of the FTP. Adverse physiological effects of
prolonged bed rest include increased insulin resistance, myopathy, reduced lung function,
impaired tissue oxygenation, and increased risk of pulmonary thromboembolism.[18] Pua et al.[19] demonstrated a significant reduction in length of stay of 1.8 days when patients
walked within 24 hours of surgery. Early mobilization after knee arthroplasty is also
associated with improved functional recovery and lower incidence of DVT.[20]
[21]
The stimulus for early walking was followed according to the methodology criteria
and all patients were discharged walking with the help of a walker and safety recommendations
made by the physiotherapy and nursing team.
In our sample, only 4 (4.08%) patients received transfusion of blood products during
the surgical procedure. A strategy that preserves the need for blood administration
is crucial to the success of the FTP. Allogeneic blood transfusion is associated with
immunomodulation and systemic volume overload.[22]
Although initially adopted in orthopedic surgeries for primary hip and knee arthroplasties,
the FTP has been increasingly applied to other orthopedic procedures, bringing benefits
to patients and reducing procedure costs.[23]
[24]
[25]
[26]
[27]
Recently, an article by the Mayo Clinic, an important reference hospital in orthopedic
surgeries in the United States, reported the benefits obtained in arthroplasty surgeries
reconciled with FTP, where patients undergoing surgery had fewer side effects related
to opioids, fewer postoperative complications, shorter hospital stay and greater cost
savings for the clinic.[28]
[29]
We believe that the reasons for the early discharge of these clinically stable patients
include several aspects, including the preoperative guidance that reduces anxiety
about the procedure and establishes that it is not necessary to stay in hospital for
a long period to recover properly, the use of the mixed anesthesia technique - spinal
anesthesia and anesthesia by local infiltration, providing more comfort to the patient
for a longer time, contributing for them to leave the acute inflammatory phase of
the postoperative period - the adequate use of blood products, contributing to avoid
a physiological lowering of the patient due to transfusion of exogenous elements,
encouraging early mobilization contributing to the return of gastrointestinal functions,
peripheral circulation of the limbs and deep circulation of the operated region, increasing
tissue perfusion with oxygen and contributing to the reduction of the inflammatory
process and finally the absence of complications such as PTE and DVT in the immediate
postoperative period.
Conclusion
The implementation of the FTP requires that a multidisciplinary team composed of surgeons,
anesthesiologists, nurses, physiotherapists, nutritionists and social workers work
together so that the steps are fulfilled and the needs are implemented, verified and
constantly evaluated to reach an acceptable index, fulfilling all the planned actions.
The FTP only works well when all parties contribute to the overall result, and weekly
follow-up and planning meetings, not only in the implementation phase, but also in
daily execution, are essential for the project to be executed correctly and effectively.
The FTP has the ability to reduce the length of hospital stay, reduce the need for
ICU use, use of blood products and high-cost analgesics, contributing to an early
and more efficient recovery of the patient, as well as reducing hospital and social
costs of returning this patient to their activities of daily living.
I draw attention to the effectiveness of the FTP in a Public Hospital and emphasize
the importance of multidisciplinary work and data auditing to better substantiate
the conclusions.