Pain Control after Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period

Journal Pre-proof Pain Control after Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period Kamil Bober, MD, Allen Kadado, MD, Michael Charters, MD, Ayooluwa Ayoola, BS, Trevor North, MD PII:

S0883-5403(20)30163-7

DOI:

https://doi.org/10.1016/j.arth.2020.02.020

Reference:

YARTH 57814

To appear in:

The Journal of Arthroplasty

Received Date: 2 December 2019 Revised Date:

2 February 2020

Accepted Date: 10 February 2020

Please cite this article as: Bober K, Kadado A, Charters M, Ayoola A, North T, Pain Control after Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period, The Journal of Arthroplasty (2020), doi: https:// doi.org/10.1016/j.arth.2020.02.020. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Inc.

Pain Control after Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period

Kamil Bober MD1, Allen Kadado MD1, Michael Charters MD1, Ayooluwa Ayoola BS1,Trevor North MD1

1

Henry Ford Hospital

Department of Orthopedic Surgery 2799 West Grand Boulevard CFP-6 Detroit, MI 48202

Corresponding Author: Kamil Bober MD, [email protected]

1

Title: Pain Control after Total Hip Arthroplasty: A Randomized Controlled Trial Determining

2

Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period

3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

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24

Abstract

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Introduction: The purpose of this randomized controlled trial was to identify if a fascia iliaca

26

block reduces postoperative pain and narcotic consumption and improves early functional

27

outcomes in primary THA performed through the mini-posterior approach.

28

Methods: Patients were recruited from September 2017 to September 2019. Eligible patients

29

received a primary THA using a mini-posterior approach with epidural anesthesia.

30

Postoperatively, patients were randomized to receive a fascia iliaca compartment block or a

31

placebo block. Numeric rating scale pain scores, narcotic consumption, and functional outcomes

32

were recorded at regular intervals postoperatively.

33

Results: Upon study completion, 122 patients were available for final analysis. There was no

34

difference in the average pain scores at any time interval between the placebo and block groups

35

during the first 24 hours (p=0.21-0.99). There was no difference in the morphine equivalents

36

consumed between the groups during any time interval postoperatively (p=0.06-0.95). Functional

37

testing showed no difference in regards to distance walked during the first therapy session (67.1

38

vs. 68.3 ft., p=0.92) and timed-up-and-go testing (63.7 vs. 66.3 sec, p=0.86). There was an

39

increased incidence of quadriceps weakness in the block group (22% vs. 0%, p=0.004) requiring

40

alterations in therapy protocols.

41

Conclusion: This randomized trial shows that a fascia iliaca compartment block does not

42

improve functional performance and does not decrease pain levels or narcotic usage after mini-

43

posterior THA, but does increase the risk of quadriceps weakness post-operatively. Based on

44

these results we do not recommend routine fascia iliaca compartment blocks after THA

45

performed with the mini-posterior approach.

46

2

47

This trial was registered at clinicaltrials.gov, study ID NCT03375112

48 49

Keywords: Fascia Iliaca, Peripheral Nerve Block, Pain, Narcotics, Total Hip Arthroplasty

50 51

This research did not receive any specific grant from funding agencies in the public, commercial,

52

or not-for-profit sectors.

53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69

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70

Introduction

71

All patients undergoing total hip arthroplasty (THA) experience pain post-operatively.[1]

72

The pain that patients experience plays an important role in their recovery and their satisfaction

73

after surgery. To help control pain, patients can receive a multimodal drug regimen, ice, and

74

physical therapy. Peripheral nerve blocks are another option to help control pain postoperatively.

75

Although there is currently little evidence for routine use of nerve blocks after THA, there have

76

been several nerve blocks that have been shown to decrease pain after total knee arthroplasty and

77

total shoulder arthroplasty.[2-4]

78

One such block that can be used to anesthetize the hip joint and surrounding soft tissues

79

is the fascia iliaca block. The fascia of the iliacus muscle is bound superlaterally by the iliac crest

80

and merges with the psoas fascia medially. The femoral nerve and lateral femoral cutaneous

81

nerve lie between this fasica iliaca and the muscle. This block is performed by injecting a large

82

amount (20-40mL) of local anesthetic under the fascia iliaca. Medial and lateral spread of the

83

local anesthetic has been shown to block the lateral femoral cutaneous nerve, the femoral nerve,

84

and branches of the obturator nerve. A diagram of the fascia iliaca block is shown in Figure 1.

85

Since the local anesthetic is injected away from the nerves and allowed to spread, it was thought

86

that it has a lower potential for femoral nerve injury and quadriceps weakness[5]. However, more

87

recent studies have questioned this finding, showing a high rate of quadriceps weakness with this

88

block[6].

89

Prior studies have shown that fascia iliaca blocks can improve pain, decrease opioid

90

consumption pre-operatively, and assist with positioning for other procedures in patients with

91

femoral neck fractures, suggesting that these blocks provide substantial intra-articular

92

analgesia.[7-10] There have also been several studies showing improved pain control and

4

93

decreased narcotic consumption with fascia iliaca blocks after hip arthroplasty.[11-13] However, a

94

majority of these studies do not comment on surgical approach or functional outcomes. The

95

fascia iliaca block primarily affects nerves to the anterior portion of the hip, and a posterior

96

approach to the hip may change the efficacy of the block since the posterior musculature and hip

97

capsule is innervated by nerves that are not affected by the fascia iliaca block.

98

To our knowledge there have been no published studies on the efficacy of these blocks

99

after THA through the posterior approach. The purpose of this randomized trial was to identify

100

whether a fascia iliaca block reduces postoperative pain and narcotic consumption and improves

101

early functional outcomes in primary THA performed through the posterior approach. Based on

102

the available literature, we hypothesized that fascia iliaca blocks would have a beneficial effect

103

on pain and narcotic consumption in this population.

104 105 106

Methods After approval by the institutional review board of the hospital, patients were recruited

107

from September 2017 to September 2019 during preoperative joints replacement classes. Patients

108

were included in the study only if they were scheduled for a primary THA under epidural

109

anesthesia. Patients were excluded if they were receiving a revision THA, if they had a

110

contraindication to epidural anesthesia, or if they had an intolerance to the local anesthetic used.

111

Written informed consent was obtained for all patients.

112

All patients underwent THA utilizing a mini-posterior approach to the hip. All patients

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received a preoperative epidural catheter and were dosed with epidural lidocaine throughout the

114

case. No periarticular injection of local anesthetic was used in any of the study patients. After

115

completion of surgery the patients were transferred to the perioperative anesthesia care unit

5

116

(PACU). In the PACU the regional anesthesia team randomized patients to the block or placebo

117

groups using a randomization table that was available to the anesthesia team. The randomization

118

sequence was created using STATA statistical software (StataCorp, College Station, TX, USA)

119

and assigned patients to 1 of 2 treatment groups. Patients randomized to the block group were

120

given a fascia iliaca block under ultrasound guidance using 40mL of 0.25% bupivacaine. The

121

local anesthetic was injected in the inguinal region, lateral to the femoral nerve. A small adhesive

122

bandage was then placed over the area of the needle insertion. Patients randomized to the

123

placebo group were prepped and draped in the same manner. An ultrasound probe was placed

124

against their skin, but no needle was introduced into the skin. A small adhesive bandage was also

125

placed over the same site. The epidural catheter was then removed from the patient. Because all

126

patients received an epidural, they could not feel whether or not a needle pierced their skin,

127

effectively blinding them to the procedure. The surgical and research teams were also blinded to

128

the procedure until completion of the study.

129

The patients were then transferred to the general orthopedics floor where they underwent

130

standard therapy protocols before being discharged. All patients ambulate the day of surgery.

131

Patients were given scheduled acetaminophen and celecoxib if they had no contraindications. Ice

132

was applied to the affected hip around the clock. Oxycodone (5-15mg) and IV morphine (2-4mg)

133

were given as needed for moderate and severe pain, respectively. For patients that did not

134

tolerate these narcotics or that were still in severe pain, tramadol (50mg), hydrocodone-

135

acetaminophen (5-10 mg), and IV hydromorphone (0.5-1mg) were available at the discretion of

136

the surgical team. Patients were discharged home with a hydrocodone-acetaminophen

137

prescription. All narcotic doses were converted to morphine equivalents prior to analysis. The

6

138

average and cumulative morphine equivalent consumption were calculated at four hour time

139

intervals after surgery.

140

Numeric pain scores (0-10) were recorded by the nursing staff at half hour intervals for

141

the first hour postoperatively, then at hourly intervals for the first four hours, at two hour

142

intervals for the first twelve hours, then at four hour intervals for the first 48 or until patient

143

discharge. Morphine equivalents consumed were recorded every 4 hours. The incidence of

144

vomiting or the requirement of anti-nausea medications was also recorded.

145

Patients worked with physical therapy starting on post-operative day zero. Data collected

146

from physical therapy notes included the ability of the patients to ambulate, distance ambulated

147

on post-operative day 1, and timed-up-and-go (TUG) test scores. These data were collected from

148

the first physical therapy note on post-operative day 0. Quadriceps muscle strength was tested

149

every morning while in the hospital and graded from 0 to 5. Quadriceps weakness was defined as

150

a strength of 3/5 or less, or knee buckling with attempted ambulation. At four weeks post-

151

operatively patients were given a questionnaire in clinic to assess their hip pain over the last

152

week, hip pain with stairs, and hip pain on uneven surfaces. Due to a low survey completion rate

153

(54%), this data was not reported in the final analysis.

154

All statistics were performed using STATA software (StataCorp, College Station, TX).

155

Student t tests were used to compare independent continuous variables. Repeated measure of

156

ANOVA testing was used to compare pain scores at each time interval. Chi square tests were

157

used to compare categorical variables. A power analysis was calculated to determine the sample

158

size used in the study. At an alpha value of 0.05 and using two sided testing, a sample size of 60

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patients per group was needed to detect a difference of 1.3 in pain scores and 9.0 in morphine

160

equivalents consumed with 80% power. Differences of this magnitude would be considered

7

161

clinically significant. Effect sizes and standard deviations were obtained from a literature

162

review.

163 164 165

Results Over the course of the study, 128 patients were recruited. The flow of patients through

166

the study is show in Figure 2. Six patients did not meet the inclusion criteria and 3 asked to leave

167

the study after randomization. This left 119 patients that were included in the final analysis. A

168

majority of patients (97%) had a diagnosis of primary osteoarthritis. There were no statistical

169

differences in the other demographic data between the two groups as shown in Table 1. A

170

minority of patients (4%) were prescribed opioids during the three months prior to surgery.

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There was no difference between groups in the proportion of patients using opioids prior to

172

surgery.

173

The average pain scores of the two groups at each time interval postoperatively are

174

shown in Figure 3. There were no significant differences in pain scores between the two groups

175

during the first 24 hours. At the 32-36 hour time interval there were only 23 patients available for

176

analysis and a statistically significant difference was found between their pain scores (5.8 vs 2.7,

177

p<0.05). At the 40-44 hour time interval there were only 17 patients available for analysis and a

178

statistically significant difference was found between their pain scores (3.8 vs 1.9, p<0.05).

179

There was no difference in the average pain score during the first 48 hours postoperatively (4.11

180

vs 3.75. p=0.34).

181 182

As seen in Figure 4, there was no statistically significant difference in the morphine equivalents consumed between the two groups at any time interval. There was also no difference

8

183

in the cumulative morphine equivalents consumed at any time interval or in the total narcotics

184

consumed in the first 48 hours postoperatively (75 vs 86, p=0.31).

185

There was no difference between the two groups in their ability to ambulate during their

186

first postoperative therapy session, the distance that they were able to ambulate, or their TUG

187

test scores. There was no difference in the incidence of nausea and vomiting or length of stay

188

between the two groups. These data are summarized in Table 2. There was an increased

189

incidence of quadriceps weakness in the block group (22% vs 0%, p=0.004). All of the patients

190

that experienced quadriceps weakness required a knee immobilizer and adjustment in therapy

191

protocols. There was no difference in the length of stay when comparing the patients that

192

experienced quadriceps weakness to those that did not (33.1h vs 35.2h, p=0.54).

193 194 195

Discussion To our knowledge, this was the first randomized study assessing the efficacy of a fascia

196

iliaca block after THA performed through the mini-posterior approach. In this study there was no

197

difference in pain scores during the first 24 hours between the block and placebo groups. The

198

differences in pain scores at 32 and 40 hours postoperatively were not thought to be clinically

199

significant since the effect of the block is expected to wear off by those time points. The duration

200

of effect of 0.25% bupivacaine used for regional nerve blocks has been shown to be less than 24

201

hours [14]. Although a meta-analysis by Zhang et. al. showed a decrease in pain scores at 12 and

202

24 hours post-operatively, the studies included in the analysis were either performed after an

203

anterior approach or no approach was reported [11].

204 205

Our study also showed no advantage of the fascia iliaca block in regards to narcotic consumption. There was no difference between groups in the morphine equivalents consumed at

9

206

any 4 hour interval or in the cumulative morphine equivalents consumed. In a small randomized

207

study, Bang et. al. showed that fascia iliaca blocks can decrease opioid consumption after hip

208

arthroplasty, although they did not show a difference in VAS pain scores [13]. This study did not

209

mention which surgical approaches were used. In another randomized trial of 88 patients,

210

Desmet et. al. showed a decrease in narcotic consumption at 24 hours post-operatively in patients

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after THA using the direct anterior approach. The results of our study suggest that the same

212

effects on pain and narcotic consumption are not obtained after a posterior approach to the hip.

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The fascia iliaca block did not offer patients improved rates of ambulation or improved

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TUG scores. This is not surprising given that both groups had the same pain scores and narcotic

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consumption. In a small retrospective study, Metesky et. al. showed that only 1 out of 20

216

patients receiving a fascia iliaca block were able to ambulate within 2 hours after THA compared

217

to 17 out of 19 patients not receiving the block[15]. The authors reported that this was likely due

218

to an increased rate of quadriceps weakness in the block group. In our study the use of knee

219

immobilizers and alterations in therapy protocols in patients with post-operative quadriceps

220

weakness may have mitigated the effect of this complication on functional outcomes.

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The only clinically significant difference between the two groups was the greatly

222

increased incidence of quadriceps weakness in the block group, and there were no patients in the

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placebo group who experienced this complication. Thirteen out of fifty nine patients receiving

224

the fascia iliaca block experienced quadriceps weakness that required a knee immobilizer and

225

changes in therapy protocols. There were no differences seen in the length of stay or pain scores

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of patients that experienced quadriceps weakness; however, this study was not powered to detect

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this difference. We believe that experiencing this complication could have an effect on patients’

228

confidence and satisfaction, which play an important role in recovery. Although these parameters

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are hard to measure, future studies can be designed to ascertain the effect of this complication.

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Prior studies of fascia iliaca blocks in total hip arthroplasty did not report the incidence of

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quadriceps weakness, although a meta-analysis by Zhang et. al. showed no increased risk of falls

232

after fascia iliaca blockade [16]. Despite this, other studies did find detrimental effects of the

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block on patient function. In a randomized trial of patients after hip arthroscopy by Behrends et.

234

al., 76% of patients receiving a fascia iliaca block reported subjective leg weakness, while only

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49% of patients in the placebo group reported a similar feeling[6]. Our results, combined with

236

these prior studies suggest that fascia iliaca blocks have a relatively high rate of quadriceps

237

weakness.

238

There are several limitations of this randomized trial. Although patients were not able to

239

feel whether they received a block or placebo, they may have been able to figure out which

240

group they were in by observing the procedure or looking under the bandage for a puncture

241

wound, compromising the blinding process. This study did not measure levels of depression or

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other conditions which have been shown to influence the perception of pain. However,

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randomizing patients to each group decreases the likelihood of this having a significant impact

244

on the results. This study was also not powered to detect a difference in length of stay or other

245

secondary outcomes, especially a subgroup analysis of patients who developed quadriceps

246

weakness. Despite these limitations, this is to date the largest randomized trial assessing the

247

efficacy of fascia iliaca blocks after mini-posterior THA, and the study was powered to detect a

248

potential difference in the primary outcomes.

249 250

Conclusion

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This double blind, randomized controlled trial showed no advantage of the fascia iliaca

252

compartment block in reducing pain, narcotic consumption, or improving short term functional

253

outcomes after mini-posterior THA. In addition, this regional anesthetic technique places

254

patients at high risk for developing quadriceps weakness postoperatively. Based on the results of

255

this study, we do not recommend routine fascia iliaca blocks in patients undergoing total hip

256

arthroplasty using a mini-posterior approach to the hip. Although the results of this study do not

257

support fascia iliaca block use after posterior THA, higher lumbosacral blocks are available

258

which may be beneficial in this patient population. Further studies are needed to elicit any

259

potential benefit of these blocks.

260 261

References

262 263

1.

Greimel, F., et al., Course of pain after total hip arthroplasty within a standardized pain

264

management concept: a prospective study examining influence, correlation, and outcome of

265

postoperative pain on 103 consecutive patients. Arch Orthop Trauma Surg, 2018. 138(12): p.

266

1639-1645.

267

2.

Kampitak, W., et al., Comparison of Adductor Canal Block Versus Local Infiltration Analgesia on

268

Postoperative Pain and Functional Outcome after Total Knee Arthroplasty: A Randomized

269

Controlled Trial. Malays Orthop J, 2018. 12(1): p. 7-14.

270

3.

Tan, Z., et al., A comparison of adductor canal block and femoral nerve block after total-knee

271

arthroplasty regarding analgesic effect, effectiveness of early rehabilitation, and lateral knee

272

pain relief in the early stage. Medicine (Baltimore), 2018. 97(48): p. e13391.

273 274

4.

Brandl, F. and K. Taeger, [The combination of general anesthesia and interscalene block in shoulder surgery]. Anaesthesist, 1991. 40(10): p. 537-42. 12

275

5.

Mudumbai, S.C., et al., An ultrasound-guided fascia iliaca catheter technique does not impair

276

ambulatory ability within a clinical pathway for total hip arthroplasty. Korean J Anesthesiol,

277

2016. 69(4): p. 368-75.

278

6.

Behrends, M., et al., Preoperative Fascia Iliaca Block Does Not Improve Analgesia after

279

Arthroscopic Hip Surgery, but Causes Quadriceps Muscles Weakness: A Randomized, Double-

280

blind Trial. Anesthesiology, 2018. 129(3): p. 536-543.

281

7.

282 283

Traumatol, 2017. 61(6): p. 383-389. 8.

284 285

Castillon, P., et al., Fascia iliaca block for pain control in hip fracture patients. Rev Esp Cir Ortop

Haines, L., et al., Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med, 2012. 43(4): p. 692-7.

9.

Ma, Y., et al., Ultrasound-guided continuous fascia iliaca compartment block for pre-operative

286

pain control in very elderly patients with hip fracture: A randomized controlled trial. Exp Ther

287

Med, 2018. 16(3): p. 1944-1952.

288

10.

289 290

block on hip fracture patients before operation. Br J Anaesth, 2018. 120(6): p. 1368-1380. 11.

291 292

Steenberg, J. and A.M. Moller, Systematic review of the effects of fascia iliaca compartment

Zhang, X.Y. and J.B. Ma, The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res, 2019. 14(1): p. 33.

12.

Desmet, M., et al., A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces

293

Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med, 2017. 42(3): p. 327-

294

333.

295 296

13.

Bang, S., et al., Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore), 2016. 95(39): p. e5018.

13

297

14.

Mulroy, M.F., et al., Femoral nerve block with 0.25% or 0.5% bupivacaine improves postoperative

298

analgesia following outpatient arthroscopic anterior cruciate ligament repair. Reg Anesth Pain

299

Med, 2001. 26(1): p. 24-9.

300

15.

Metesky JL, C.J., Rosenblatt M, Enhanced recovery after surgery pathway: The use of fascia iliaca

301

blocks causes delayed ambulation after total hip arthroplasty. World J Anesthesiol, 2019. 8(2): p.

302

13-18.

303 304

16.

Zhang, P., et al., The efficiency and safety of fascia iliaca block for pain control after total joint arthroplasty: A meta-analysis. Medicine (Baltimore), 2017. 96(15): p. e6592.

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Acknowledgements The authors would like to thank Lauren Dawley PAC, Lana Jones RN, and Michelle Morris RN for their help with patient recruitment for this study. We like to thank Jessica Yee MD for creating the illustration of the fascia iliaca block.

Table 1

Variable

Tx (n = 59)

Placebo (n=60)

P value

Age

62.9

63.6

0.77

Gender (f)

31 (53%)

36 (60%)

0.56

Primary OA

57 (97%)

59(98%)

0.60

Smoking

2 (3%)

3 (5%)

0.59

Prior Opioids

2 (3%)

2 (3%)

0.94

Table 2

Outcomes

Treatment (n=59)

Placebo (n=60)

P value

Total Narcotics Consumed

75.3

86.0

0.310

Average Pain

3.75

4.11

0.344

Ability to ambulate with PT

56 (95%)

59 (98%)

0.340

Distance walked with PT (ft.)

67.1

68.3

0.918

Timed-up-and-go test (s)

63.7

66.3

0.858

Nausea/Vomiting

12 (20%)

14 (23%)

0.50

Quadriceps weakness

13 (22%)

0 (0%)

0.004

Length of Stay (h)

35.1

35.2

0.966

1

Figure 1

2

3 4 5 6 7 8 9 10 11 12 13 1

14

Figure 2

15

128 patients consented

16 17 18

6 patients could not receive epidural 122 patients randomized

19 20 21 22 23

60 received placebo

62 received block

24

3 patients asked to leave study

25 26

60 finished study

59 finished study

27 28 29 30 31 32 33 34 35 36 37 2

38

Figure 3

39 40

7

41

6

43 44 45 46 47

Average Pain Score

42

5 4 Block Group

3

Placebo Group 2 1

48

44-48

28-32 32-36 36-40 40-44

16-20 20-24 24-28

6-8 8-10 10-12 12-16

2-3 3-4 4-6

0-0.5 0.5-1 1-2

0 49 50 51

Time Interval Post OPeratively (Hours)

52 53 54 55 56 57 58 59 60 61 3

62

Figure 4

63

18

64

p = 0.06

16

66 67 68 69 70 71 72

Cumulative Morphine Equivalents

65

14

p = 0.89 p = 0.26

12 p = 0.77

p = 0.60

10

p = 0.95

8

Block Group

6

Placebo Group

4 2 0 0-4h

4-8h

8-12h

12-16h

16-20h

20-24h

Hours Postoperatively

73 74 75

4

Table Legends Table 1: Comparison of patient demographics in each group Table 2: Comparison of secondary outcomes in each group

Figure Legends Figure 1: Illustration of the fascia iliaca block. The needle is inserted lateral to the femoral nerve and through the fascia lata and fascia iliaca prior to injection of local anesthetic. Figure 2: Study design and flow of patients through the study Figure 3: Average numeric rating scale pain scores at each time interval post operatively Figure 4: Morphine equivalents consumed at four hour time intervals postoperatively