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Corresponding author. Department of Life, Health & Environmental Sciences (MESVA), University of L'Aquila, Piazzale Tommasi 1, 67100, Coppito - L'Aquila, Italy.
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, ItalyUOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, ItalyUOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, ItalyUOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, ItalyUOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
Department of Life, Health and Environmental Sciences, University of L'Aquila, Via Vetoio, Coppito 2, 67100, L'Aquila, ItalyUOSD, Department of Mini-invasive and Computer-assisting Orthopaedic Surgery, San Salvatore Hospital, Via L. Natali 1, 67100, L'aquila, Italy
Total knee arthroplasty (TKA) is a common procedure for improving mobility and quality of life in patients with osteoarthritis. Postoperative pain control management after TKA is still a concern as it relates to patients satisfaction and functional recovery.
Many anesthetic regimens and techniques have been explored to decrease postoperative pain and enhance the fast recovery after TKA. The aim of this study was to evaluate the best anesthetic treatment in pain control after TKA.
Methods
51 patients were included in a randomized prospective study and distributed in three groups. The first group (CG) in which no analgesic protocol was implemented (control group). The second group (LIA group) received an intraoperative local infiltration anesthesia (LIA) (60 ml mixture of two ropivacaine 75mg/10 mL + adrenaline 100μg/10 mL + physiological solution). The third group (FNB group) had only a femoral nerve block (FNB). Continuous outcomes including visual analogue scale (VAS) at 5,24,48 h and at 1 week, morphine consumption and range of motion (ROM) at 1,2,7 days.
Results
There was significant difference between all groups (p < 0,001) in terms of the VAS score: at 5h after surgery (4.55,2.15,1.82); at 24h (4.15,2.65,3.36); at 48h (3.85,2.45,2.73); at 1 week (2.95,1.80, 1.64), respectively for groups CG, LIA, FNB.
ROM was better in LIA and FNB groups than CG: at 1 die after surgery (44°,50°,54°); at 3 dies (69°,70°,71°); at 7 dies (91°,98°,98°), respectively for groups CG, LIA, FNB (p < 0,001).
Discussion
LIA and FNB groups both showed a significant reduction at VAS score, better range of motion and less morphine consumption than CG (control group). LIA group has obtained a constant pain control in the postoperative days; FNB group had a good pain control in the hours after surgery, with a decrease in efficacy in the following days.
Conclusion
Further studies are still needed in order to define LIA as the reference pain management in TKA.
Total joint arthroplasty is one of the most successful surgical procedures. Management of pain following total joint arthroplasty is an important aspect of this procedure.
The number of primary total knee arthroplasty (TKA) procedures will be reached at 3.48 million in 2030 in the United States.
Pain after TKA follows many specific characteristics: there is a higher occurrence during mobilization than at rest, the intensity usually peaks from 3 to 6 h after surgery and persists at least for 72 hours
There are several methods available for postoperative analgesia management, including systemic opioids, epidural local anesthetics, peripheral nerve block, and local anesthetic infiltration analgesia. Parenteral opioids are associated with adverse effects including nausea, pruritus, and respiratory depression,
Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial.
The use of continuous femoral nerve blocks versus extended release epidural morphine: a study comparing outcomes in total knee arthroplasty procedures.
Local infiltration analgesia (LIA) and femoral nerve block (FNB) have shown better analgesia and less side effects. Many authors have shown that LIA provide improved pain relief compared with no injection,
but the analgesic effect of LIA is connected with the ingredients of the cocktail. The goal of our study was to evaluate the best anesthetic treatment in pain control and functional outcomes after TKA.
2. Materials and methods
2.1 Study design
This is a monocentric prospective, patient- and assessor-blinded, randomized controlled clinical trial. All patients provided written informed consent. From January 2016 to July 2017 all patients undergoing primary TKA, in our hospital, were recruited. Exclusion criteria were: allergies to the drugs used in this study, neuromuscular disease, sensory disturbances of the legs, severe diabetes, heart failure, renal dysfunction, and liver dysfunction, chronic users of opioids or non-steroidal anti-inflammatory drugs (NSAIDs), a history of deep vein thrombosis, and previous knee surgery. Patients eligible for this study were randomized into three groups by sealed envelope.
2.2 Anesthetic, surgical techniques and postoperative care
Spinal anesthesia was used for all patients. All operations were performed by a single senior surgeon implanting the same phrostetic model of cruciate retaining TKA and using a tourniquet. At the end of the surgery a wound drain was applied to all patients. After surgery, all patients were given enoxaparin 4000 UI for 2 week, 2g cefazolin twice for 3 days. Ketoprofen 160 mg/2 ml and oxycodon-naloxon 10/5 mg twice a day for a week were administered to all patients for pain control.
Patients who received only this analgesic treatment represented the control group (CG).
A second group of patients was treated adding a local infiltration anesthesia (LIA) to the baseline pain treatment (LIA group); specifically, a solution containing 20 ml of ropivacaine (150 mg of ropivacaine 7,5 mg/ml), 10 ml of adrenaline (1 mg ml−1) and 30 ml of physiological solution was undertaken, by the surgeon, as follows: 40 ml administered into the posterior capsule, collateral ligaments, and quadriceps muscles before implant fixation; 20 ml administered subcutaneously around the skin incision before the wound closure; in all areas the procedure was performed sucking before the injection to avoid intravasal administration, and particular precaution has been used in the posterior capsule for the risks connected with neurovascular bundles, as the technique described by Dysart et al.
A randomized, multicenter, double-blind study of local infiltration analgesia with liposomal bupivacaine for postsurgical pain following total knee arthroplasty: rationale and design of the PILLAR trial.
A third group of patients was treated adding a femoral nerve block (FNB) to the baseline pain treatment (FNB group); the same anesthesiologist conducted one-shot FNB with 20 ml of chirocaine (10ml/5 mg) using an ultrasound-guided technique in combination with a nerve stimulus technique.
If analgesia in all three groups was not sufficient and patients could not tolerate pain, oxycodon-naloxon dose was increased to 15/7,5 mg twice a day until discharge: patients were constantly monitored during all the time of hospital stay and basic therapy was immediately adapted for the control of algic symptoms.
The wound drain was removed 24 h after the operation to all patients.
All patients followed the same rehabilitation protocol: hamstring stretching after 8 h from surgery, weightbearing after 24 h from the surgery, walking and stairs climbing after 48 h from surgery; active and passive (through the use ok a kinetic device) movements were started from the day after surgery for 25 min twice for a week. Maximum knee flexion angle was recorded by physiotherapists on post-operative days 1,2, and 7.
2.3 Outcome measures
Self-reported pain at rest was assessed using VAS score (0 = no pain; 10 = worst pain), at 5, 24, 48 h and then 7 days after surgery. The blinded assessor recorded cases in which the dose of opioid drug was increased and all major complications, nausea, vomiting, and toxic symptoms of anesthetic drugs including dizziness, tinnitus, tongue numbness, neurapraxia and spasm. The passive knee range of motion (ROM) displayed in the kinetic device at 24,48 h and then 7 days after surgery, was also recorded by a blinded physioterhapist.
2.4 Statistics
All continuous data of VAS and ROM were expressed as means and standard deviations of the mean. A two-factor analysis of variance (ANOVA) for repeated measures, after logarithmic transformation of variables in the event of non-normality of data, was performed to assess differences between groups.
Chi-squared test was used to verify differences between groups for increasing dose of the opioid and for complications frequency.
P-values less than 0.05 were taken as statistically significant.
Statistical analysis was carried out using SAS System version 9.4 (SAS, Cary, NC, USA) and Med Calc statistical software version 13.3.1 (MedCalc Software bvba, Ostend, Belgium).
The study has been based on an estimated sample size of 60 patients, with a ratio 1:1:1 for the 3 types of treatment (CG, LIA, FNB), which was calculated to be adequate to achieve 90% power to detect a medium effect size (Cohen's f: 0.25) with 2 df and an α of 0.05 on the VAS values between the 3 types of treatment. Statistical power has been assessed by G*POWER Version 3.1.9.2.
Preoperative characteristics of all patients were evaluated through Kruskal-Wallis test except for Sex for which was used the Chi-squared test.
3. Results
A total of 51 patients were successfully recruited: 20 patients were assigned to CG group, 20 patients to LIA group and 11 patients to FNB group. Demographic and clinical characteristics and mean tourniquet duration were similar in the 3 treatment groups and did not affected the following results (Table 1). Results of VAS score and ROM for each group are shown in the table below (Table 2; Fig. 1, Fig. 2).
Table 1Baseline characteristics.
Characteristic
GRUPPO A (CG) (n = 20)
GRUPPO B (LIA) (n = 20)
GRUPPO B (FNB) (n = 11)
P value
Sex (M:F)
(8:12)
(5:15)
(4:7)
0.59
Age (y) m (range)
74.5 (60–91)
75.7 (52–84)
78.2 (70–84)
0.32
BMI m (range)
27.1 (23.5–36.7)
28.6 (23.5–36.8)
26.5 (24.2–28,4)
0.28
ASA m
1.85
1.85
1.81
0.97
ROM m min-max
2.75–106.7
2.25–106
4.09–105
0.25
Tourniquet duration (min)
94.75
95
95
0.98
BMI: Body Mass Index, m: mean value, ROM: range of motion, ASA: American Score Anesthesiologists.
Fig. 1Post-operative pain after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
Fig. 2Knee Range of motion (ROM) after total knee arthroplasty. Data are expressed as mean ± SD and are analyzed using the ANOVA test. CG control group, LIA local infiltration analgesia, FNB femoral nerve block.
In any case patients suffered of an intolerable pain and, if requested, the adjustment of baseline oral therapy was sufficient in every case to reduce the algic symptoms. No major adverse events and toxic symptoms of anesthetic drugs were described after surgery.
For the first 24 h no patients asked or had so much pain discomfort to need an increased dose of opioid drug; after 48 h a higher dose of oxycodon-naloxon (15/7,5 mg) was necessary for 16, 4 and 2 patients of CG, LIA and FNB groups respectively (the chi-square test was 18.2373; p < 0,00011); of these patients 13, 3 and 1 patients of CG, LIA and FNB groups respectively suffered from nausea and/or vomiting (the chi-square test was 1.0029; p = 0,60539). No patients of those that did not need an augmentation of opioid dose, suffered from gastrointestinal disorders.
4. Discussion
There is debate in literature about the best method of postoperative pain management after TKA. The main objective of this study was to evaluate the best and safe anesthetic procedure between oral therapy, LIA and FNB in this type of surgery.
The main findings of our study was that FNB was more effective than LIA in reducing pain immediately after surgery (within 8 h); however, FNB was less effective than LIA at 24 and 48 h after the surgery. There are two possible reasons for the lower analgesic effect of LIA immediately after the surgery. First, the anesthesiologist used an ultrasound guidance technique and nerve stimulation equipment to carry out FNB, therefore accurate injection of the anesthetic agent to the femoral nerve was achieved. In comparison, the surgeons blindly injected the anesthetic agent to the sensory nerve at the rear of knee joint in the LIA group, which may result in variability among the analgesic effect of LIA. The second reason is that LIA was carried out during the surgery (before implant fixation and before wound closure), therefore the analgesic effect in LIA group might not have taken effect at the end of the surgery and at 8 h after surgery. Since the patients in LIA group expressed less pain than FNB group at 24 and 48 h after the surgery, LIA may have a longer acting time than FNB. Our results showed that both patients in LIA and FNB groups would experience enough reduction in pain after surgery than patients in control group. Our result is supported by a study comparing FNB and periarticular infiltration reporting that patients in the LIA group had a significantly lower visual analog scale score at rest 1 day after surgery than those in the continuous FNB group; the opioid consumption during the initial 24 h was significantly lower in the LIA group.
Our results show that postoperative VAS score remained at a low level in LIA and FNB groups than the control group, and sufficient post-operative analgesia was achieved with either FNB or LIA technique. The time needed to perform FNB or LIA is also important to shorten the anesthetic time and to improve the efficiency of the operating room. LIA is an easy and fast technique, and surgeons can eliminate wasting time by injecting the drugs into the posterior of knee joint capsule while preparing the cement for implant fixation. Also, an accurate and fast FNB procedure was achieved using an ultrasound aided peripheral nerve stimulated technique, which offers the potential benefit of accelerating the procedure, reducing the dose of local anesthetics, and resulting in higher block success rates.
Singh et al. comparing periarticular infiltration of liposomal bupivacaine to conventional analgesic regimens for total knee arthroplasty published till June 2016 were searched in medical database and concluded that liposomal bupivacaine infiltration has questionable clinical advantage, as it marginally shortens patient's hospital stay especially in comparison with patients receiving FNB; compared with conventional regimens, it can provide slightly superior yet sustained (till second postoperative day) perioperative analgesia; high heterogeneity suggests need for standardization of infiltration techniques for better predictability of results.
Wang et al. recently reported that intraoperative periarticular liposomal bupivacaine infiltration, compared to standard bupivacaine, promotes superior pain relief and less morphine consumption after total knee arthroplasty; in addition, there were fewer side effects associated with liposomal bupivacaine infiltration.
Comparison of peri-articular liposomal bupivacaine and standard bupivacaine for postsurgical analgesia in total knee arthroplasty: a systematic review and meta-analysis.
Liposomal bupivacaine, owing to its pharmacological properties of long duration of action should have logically demonstrated similar benefits over conventional periarticular local anes-thetic injections as well.
concluded that continuous FNB had better KSS and Western Ontario and McMaster Universities score than that of periarticular infiltration in their study. While study by Fan et al.
showed no significant differences between LIA and FNB groups in terms of Visual Analogue Scale (VAS), Knee Society Score, and Range of Motion (ROM) before and after surgery. In our study, we found that FNB showed better ROM than group LIA on postoperative day 1 and showed similar ROM on post-operative days 2 and 7, which means there was no significant difference of patients knee function between LIA and FNB groups in the long term. The group of control showed less passive knee flexion angle than LIA and FNB groups on postoperative days 1, 2 and 7. The result was the same as those in the studies of Uesugi,
Finally, after 48 h of surgery, 16 patients of CG group (80%), 4 of LIA group (20%) and 2 of FNB group (18,2%), required an increase in oxycodon-naloxon dose to achieve good pain control.
Of these patients (43,13%), 13 patients of CG group (65%), 3 of LIA group (15%) and 1 of FNB group (9,09%) had side effects like nausea and vomiting.
Given that in patients who did not require an increase in oxycodone-naloxon dose, these effects were not observed, it can be inferred that the use of a single single oral therapy exposes more to the risk of a rescue dose with its consequent side effects.
Problems for wound healing occasionally occurred in TKA surgeries, especially the cocktail used for local infiltration contains steroids. In our study used cocktail without steroids; muscles, fascia, and subcutaneous were sutured layer by layer. With good control of cocktail consumption and careful suture of incision, there were no wound healing problems in both groups.
There are several limitations to be noted regarding this study. First of all there is an unequal distribution of patients in each group (20,20,11): the calculated power requested is to obtain a total of sixty patients but, since 10 patients were really dissatisfied for quadriceps weakness with difficulties in gait, active contraction, stair climbing and chair rising, we decided to evaluate if these side effects were connected to one specific treatment. We found that they were all assigned to envelope of FNB group. For this and ethical reasons, according to the anesthesiologists, we decided to interrupt this type of treatment excluding those sealed enveloped; the randomization was prosecuted and completed for CG and LIA groups. Another possible limitation of this study may be that each group received more than one drug to relieve pain, which synergistically influence patients pain level and affect the outcomes of VAS and morphine consumption. However, multimodal analgesia could reduce morphine consumption and get better pain control, which was advocated in clinic.
Parecoxib sodium, a parenteral cyclooxygenase 2 selective inhibitor, improves morphine analgesia and is opioid-sparing following total hip arthroplasty.
Thirdly, randomization by sealed envelope is open to selection bias, and a better method would have been computer generated off-site randomization to reduce this bias. Fourthly, combining various implant models may have an unknown effect on postoperative pain and knee function. Fifthly, there is no standardization of injection technique. Finally, our study is a single-center clinic trial, and selective bias is unavoidable. So multicenter studies that are better planned are needed in the future.
5. Conclusion
Local infiltration analgesia is increasingly used in total knee arthroplasty in spite of relatively few positive randomized trials published so far.
Local anesthetics after total knee arthroplasty: intraarticular or extraarticular administration? A randomized, double- blind, placebo controlled study.
LIA provided a similar analgesic effect to the FNBs with a low incidence of complications, better postoperative pain relief and resulted in better inflammatory control without increasing complications. We recommend the use of LIA over the use of continuous FNB for pain relief after TKA. However, the combination of LIA and FNB could be an alternative way of anesthesia for TKA. Finally, in total knee arthroplasty, studies are required to define the major origin of pain, whether it is subcutaneous, capsular, anterior/posterior, to help implement effective treatment.
Conflicts of interest
Dr. Paglia Alessandro: None.
Dr. Goderecci Remo: None.
Dr. Ciprietti Norman: None.
Dr. Lagorio Matteo: None.
Prof. Necozione Stefano: None.
Prof. Calvisi Vittorio: None.
References
Kurtz S.
Ong K.
Lau E.
et al.
Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030.
Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial.
The use of continuous femoral nerve blocks versus extended release epidural morphine: a study comparing outcomes in total knee arthroplasty procedures.
A randomized, multicenter, double-blind study of local infiltration analgesia with liposomal bupivacaine for postsurgical pain following total knee arthroplasty: rationale and design of the PILLAR trial.
Comparison of peri-articular liposomal bupivacaine and standard bupivacaine for postsurgical analgesia in total knee arthroplasty: a systematic review and meta-analysis.
Parecoxib sodium, a parenteral cyclooxygenase 2 selective inhibitor, improves morphine analgesia and is opioid-sparing following total hip arthroplasty.
Local anesthetics after total knee arthroplasty: intraarticular or extraarticular administration? A randomized, double- blind, placebo controlled study.
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