超声引导下仰卧位腰丛阻滞与髂筋膜阻滞对高龄患者髋关节置换镇痛的比较:单中心、随机、对照临床试验
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摘要
背景:高龄患者接受髋关节置换,手术的麻醉是很重要的环节。腰丛以及髂筋膜阻滞都是髋关节置换常用的麻醉阻滞方法。目的:试验拟观察超声引导下仰卧位腰丛阻滞与多角度多点髂筋膜阻滞在高龄髋关节置换患者围术期镇痛效果,以筛选出对此类患者的最佳镇痛方案。方法:研究为前瞻性、单中心、随机、对照临床试验。拟收集中国安徽省六安世立医院的高龄髋关节置换住院患者208例,随机分为2组,每组104例,腰丛组行仰卧位腰丛神经阻滞后联合喉罩全身麻醉,髂筋膜组行多角度多点髂筋膜神经阻滞后联合喉罩全身麻醉,麻醉后两组进行髋关节置换。术后随访24h。试验经六安世立医院医学伦理委员会批准(批准号:PJ2018-001,审批时间:2018年3月),方案版本号1.0。参与试验的患者在充分了解治疗方案的前提下签署"知情同意书"。结果与结论:研究的主要结局指标为术后24 h以目测类比评分法评估术后镇痛效果;次要观察指标为术后2,6,12 h的目测类比评分变化,术中各时间点[喉罩置入时(T0)、手术切皮时(T1)、手术扩髓时(T2)、假体植入时(T3)、缝切口时(T4)、入复苏室后(T5)]心率、平均动脉压和血氧饱和度变化,术中舒芬太尼、佩尔地平、麻黄碱用量,术后2,6,12,24h静脉自控镇痛用药总量及不良反应发生率。课题组前期(2018年3月至9月)已完成了60例高龄髋关节置换患者的小样本试验结果,腰丛组30例术中舒芬太尼、佩尔地平及麻黄碱的用量明显低于髂筋膜组(P <0.05);髂筋膜组30例T2至T5时的心率与腰丛组相应时间点相比明显升高(P <0.05),且在T1,T2,T3,T5时心率大于同组T0 (P <0.05);同时髂筋膜组T1至T5时的平均动脉压高于腰丛组(P <0.05),在T1至T4时的平均动脉压高于同组T0 (P <0.05);而腰丛组T3,T4时的平均动脉压略低于同组T0 (P <0.05)。腰丛组术后6,12,24 h疼痛目测类比评分低于髂筋膜组(P <0.05)。试验期望证实,与多角度多点髂筋膜阻滞相比,超声引导下仰卧位腰丛神经阻滞联合全身麻醉可以有效的维持髋关节置换过程中血流动力学指标的稳定性,为高龄髋关节置换者提供良好的术后镇痛效果。试验已在中国临床试验注册中心注册(注册号:Chi CTR1800019888),注册时间:2018年12月7日。
BACKGROUND: Anesthesia is an important part of hip replacement in older adult patients. Lumbar plexus block and iliac fascia block are common block methods in hip replacement. OBJECTIVE: To investigate the analgesic effect of ultrasound-guided lumbar plexus block in supine position versus multi-angle multi-point iliac fascia block during hip replacement in older adult patients to screen the optimal analgesic regimen. METHODS: This prospective, single-center, randomized, controlled trial will include 208 older adult patients scheduled to undergo hip replacement from wards of Lu'an Civily Hospital in China. These patients will be randomly assigned to two groups(n = 104/group). In the lumbar plexus block group, patients will undergo lumbar plexus block in supine position, general anesthesia using a laryngeal mask airway and later hip replacement. In the iliac fascia block group, patients will undergo multi-angle multi-point iliac fascia block, general anesthesia using a laryngeal mask airway and later hip replacement. After surgery, all patients will be followed up for 24 hours. This study was approved by Medical Ethics Committee of Lu'an Civily Hospital in China in March 2018(approval No. PJ2018-001). The study protocol is 1.0. Patients participating in this study will sign informed consent after fully understanding the study protocol. RESULTS AND CONCLUSION: The primary outcome measure of this study is Visual Analog Scale score at 24 hours post-surgery, which is used to evaluate postoperative analgesic effect. The secondary outcome measures of this study are Visual Analog Scale score at 2, 6 and 12 hours post-surgery, heart rate at various time points during the surgery [laryngeal mask placement(T0), surgical incision(T1), surgical reaming(T2), prosthesis implantation(T3), incision suture(T4), and resuscitation(T5)], mean arterial pressure, blood oxygen saturation, intraoperative sufentanil, perdipine, and ephedrine dosages, total amount of intravenous patient controlled analgesics at 2, 6, 12, and 24 hours post-surgery, and incidence of adverse reactions. Results of a pilot study involving 60 older adult patients who underwent hip replacement from March to September 2018 showed that intraoperative sufentanil, perdipine, and ephedrine dosages were significantly lower in the lumbar plexus block group(n=30) than in the iliac fascia block group(n=30; P < 0.05); heart rate at T2, T3, T4 and T5 was significantly lower in the lumbar plexus block group than in the iliac fascia block group(P < 0.05); heart rate at T1, T2, T3, T5 was significantly greater than that at T0 in the iliac fascia block group(P < 0.05); mean arterial pressure at T1, T2, T3, T4 and T5 was significantly lower in the lumbar plexus block group than that in the iliac fascia block group(P < 0.05), and mean arterial pressure at T1, T2, T3 and T4 was significantly higher than that at T0 in the iliac fascia block group(P < 0.05). Mean arterial pressure at T3 and T4 was significantly lower than that at T0 in the lumbar plexus block group(P < 0.05). Visual Analogue Scale score at 6, 12 and 24 hours post-surgery was significantly higher in the iliac fascia block group than in the lumbar plexus block group(P < 0.05). Results from this study will provide evidence indicating whether ultrasound-guided lumbar plexus block in supine position in combination with general anesthesia can more effectively maintain stable hemodynamic index during hip replacement and exhibits more encouraging postoperative analgesic effects in older adult patients than multi-angle multi-point iliac fascia block. This trial had been registered in the Chinese Clinical Trial Registry(registration number: ChiCTR1800019888) on December 7, 2018.
BACKGROUND: Anesthesia is an important part of hip replacement in older adult patients. Lumbar plexus block and iliac fascia block are common block methods in hip replacement. OBJECTIVE: To investigate the analgesic effect of ultrasound-guided lumbar plexus block in supine position versus multi-angle multi-point iliac fascia block during hip replacement in older adult patients to screen the optimal analgesic regimen. METHODS: This prospective, single-center, randomized, controlled trial will include 208 older adult patients scheduled to undergo hip replacement from wards of Lu'an Civily Hospital in China. These patients will be randomly assigned to two groups(n = 104/group). In the lumbar plexus block group, patients will undergo lumbar plexus block in supine position, general anesthesia using a laryngeal mask airway and later hip replacement. In the iliac fascia block group, patients will undergo multi-angle multi-point iliac fascia block, general anesthesia using a laryngeal mask airway and later hip replacement. After surgery, all patients will be followed up for 24 hours. This study was approved by Medical Ethics Committee of Lu'an Civily Hospital in China in March 2018(approval No. PJ2018-001). The study protocol is 1.0. Patients participating in this study will sign informed consent after fully understanding the study protocol. RESULTS AND CONCLUSION: The primary outcome measure of this study is Visual Analog Scale score at 24 hours post-surgery, which is used to evaluate postoperative analgesic effect. The secondary outcome measures of this study are Visual Analog Scale score at 2, 6 and 12 hours post-surgery, heart rate at various time points during the surgery [laryngeal mask placement(T0), surgical incision(T1), surgical reaming(T2), prosthesis implantation(T3), incision suture(T4), and resuscitation(T5)], mean arterial pressure, blood oxygen saturation, intraoperative sufentanil, perdipine, and ephedrine dosages, total amount of intravenous patient controlled analgesics at 2, 6, 12, and 24 hours post-surgery, and incidence of adverse reactions. Results of a pilot study involving 60 older adult patients who underwent hip replacement from March to September 2018 showed that intraoperative sufentanil, perdipine, and ephedrine dosages were significantly lower in the lumbar plexus block group(n=30) than in the iliac fascia block group(n=30; P < 0.05); heart rate at T2, T3, T4 and T5 was significantly lower in the lumbar plexus block group than in the iliac fascia block group(P < 0.05); heart rate at T1, T2, T3, T5 was significantly greater than that at T0 in the iliac fascia block group(P < 0.05); mean arterial pressure at T1, T2, T3, T4 and T5 was significantly lower in the lumbar plexus block group than that in the iliac fascia block group(P < 0.05), and mean arterial pressure at T1, T2, T3 and T4 was significantly higher than that at T0 in the iliac fascia block group(P < 0.05). Mean arterial pressure at T3 and T4 was significantly lower than that at T0 in the lumbar plexus block group(P < 0.05). Visual Analogue Scale score at 6, 12 and 24 hours post-surgery was significantly higher in the iliac fascia block group than in the lumbar plexus block group(P < 0.05). Results from this study will provide evidence indicating whether ultrasound-guided lumbar plexus block in supine position in combination with general anesthesia can more effectively maintain stable hemodynamic index during hip replacement and exhibits more encouraging postoperative analgesic effects in older adult patients than multi-angle multi-point iliac fascia block. This trial had been registered in the Chinese Clinical Trial Registry(registration number: ChiCTR1800019888) on December 7, 2018.
引文
[1]Kang ZW, Zhang YH, Yang ZQ. Classification and reconstruction of acetabular defects in revision total hip arthroplasty. Zhongguo Gu Shang. 2018;31(9):874-879.
[2]Lang JZ, Wu CC, Jin JF, et al. Analysis of influence of sarcopenia on early postoperative function of femoral neck fracture by hip arthroplasty. Zhongguo Gu Shang. 2018;31(9):835-839.
[3]Wang F, Meng C, Cao XB, et al. Hemiarthroplasty for the treatment of complicated femoral intertrochanteric fracture in elderly patients.Zhongguo Gu Shang. 2018;31(9):818-823.
[4]Matar HE, Stritch P, Emms N. Custom-made cement-linked distal femoral replacement for interprosthetic femur fractures:five-year follow-up. J Long Term Eff Med Implants. 2018;28(2):119-123.
[5]Esen E, Dur H, Atao?lu MB, et al. Evaluation of proximal femoral nail-antirotation and cemented, bipolar hemiarthroplasty with calcar replacement in treatment of intertrochanteric femoral fractures in terms of mortality and morbidity ratios. Eklem Hastalik Cerrahisi. 2017;28(1):35-40.
[6]Ercin E, Bilgili MG, Sari C, et al. Risk factors for mortality in geriatric hip fractures:a compressional study of different surgical procedures in785 consecutive patients. Eur J Orthop Surg Traumatol. 2017;27(1):101-106.
[7]Capdevila A, Navarro M, Bori G, et al. Incidence and Risk Factors for Infection When Teicoplanin Is Included for Prophylaxis in Patients with Hip Fracture. Surg Infect(Larchmt). 2016;17(4):381-384.
[8]Guo Y, Jia P, Zhang J, et al. Prevalence and risk factors of postoperative delirium in elderly hip fracture patients. J Int Med Res.2016;44(2):317-327.
[9]De Luca ML, Ciccarello M, Martorana M, et al. Pain monitoring and management in a rehabilitation setting after total joint replacement.Medicine(Baltimore). 2018;97(40):e12484.
[10]Katchy AU, Anyaehie UE, Nwadinigwe CU, et al. Total hip replacement in sickle cell disorder:a preliminary report of challenges and early outcome of 21 consecutive patients. Niger J Clin Pract. 2018;21(4):492-495.
[11]Li J, ke XJ, Liu Y, et al. The clinical application of lumbar plexus-the first posterior sacral foramina block for hip arthroplasty in elderly patients. Zhonghua Yi Xue Za Zhi. 2016;96(43):3470-3473.
[12]罗声臻,潘永英,盛福庭,等.超声引导髂筋膜腔隙与髂腹下/髂腹股沟神经复合阻滞在老年患者髋关节置换术术后镇痛中的作用[J].国际麻醉学与复苏杂志,2017,38(6):506-509,514.
[13]Mei B, Zha H, Lu X, et al. Peripheral nerve block as a supplement to light or deep general anesthesia in elderly patients receiving total hip arthroplasty:a prospective randomized study. Clin J Pain. 2017;33(12):1053-59.
[14]Ke X, Li J, Liu Y, et al. Surgical anesthesia with a combination of T12paravertebral block and lumbar plexus, sacral plexus block for hip replacement in ankylosing spondylitis:CARE-compliant 4 case reports.BMC Anesthesiol. 2017;17(1):86.
[15]Newman B, Mc Carthy L, Thomas PW, et al. A comparison of preoperative nerve stimulator-guided femoral nerve block and fascia iliacacompartment block in patients with a femoral neck fracture.Anaesthesia. 2013;68(9):899-903.
[16]Aksoy M, Dostbil A, Ince I, et al. Continuous spinal anaesthesia versus ultrasound-guided combined psoas compartment-sciatic nerve block for hip replacement surgery in elderly high-risk patients:a prospective randomised study. BMC Anesthesiol. 2014;14:99.
[17]Yu B, He M, Cai GY, et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly:a randomized controlled clinical trial(CONSORT). Medicine(Baltimore). 2016;95(42):e5056.
[18]Kuchálik J, Magnuson A, Tina E, et al. Does local infiltration analgesia reduce peri-operative inflammation following total hip arthroplasty? A randomized, double-blind study. BMC Anesthesiol. 2017;17(1):63.
[19]Liu Y, Ke X, Wu X, et al. Ultrasound-guided lumbar plexus block in supine position. Anesthesiology. 2018;128(4):812.
[20]张大志,常颖,杨庆国.超声引导下髂筋膜间隙不同角度多点阻滞与单点阻滞效果的比较[J].临床麻醉学杂志,2015,31(1):50-52.
[21]Flytstr?m I, Stenberg B, Svensson?, et al. Patients'visual analogue scale:a useful method for assessing psoriasis severity. Acta Derm Venereol. 2012;92(4):347-348.
[22]陆小龙,梅斌,陈士寿,等.超声引导下腰骶丛神经阻滞联合全麻在高龄患者髋关节置换术的临床应用[J].临床麻醉学杂志,2016,32(3):237-240.
[23]Karmakar MK, Li JW, Kwok WH, Hadzic A. Ultrasound-guided lumbar plexus block using a transverse scan through the lumbar intertransverse space:a prospective case series. Reg Anesth Pain Med 2015;40:75-81.
[24]Strid JMC, Sauter AR, Ullensvang K, et al. Ultrasound-guided lumbar plexus block in volunteers:a randomized controlled trial. Br J Anaesth.2017;118:430-438.
[25]Inan N, Akin Takmaz S, Iltar S, et al. The effects oftwo different multimodal analgesic regimens in total hip replacement surgery. Agri.2009;21(2):69-74.
[2]Lang JZ, Wu CC, Jin JF, et al. Analysis of influence of sarcopenia on early postoperative function of femoral neck fracture by hip arthroplasty. Zhongguo Gu Shang. 2018;31(9):835-839.
[3]Wang F, Meng C, Cao XB, et al. Hemiarthroplasty for the treatment of complicated femoral intertrochanteric fracture in elderly patients.Zhongguo Gu Shang. 2018;31(9):818-823.
[4]Matar HE, Stritch P, Emms N. Custom-made cement-linked distal femoral replacement for interprosthetic femur fractures:five-year follow-up. J Long Term Eff Med Implants. 2018;28(2):119-123.
[5]Esen E, Dur H, Atao?lu MB, et al. Evaluation of proximal femoral nail-antirotation and cemented, bipolar hemiarthroplasty with calcar replacement in treatment of intertrochanteric femoral fractures in terms of mortality and morbidity ratios. Eklem Hastalik Cerrahisi. 2017;28(1):35-40.
[6]Ercin E, Bilgili MG, Sari C, et al. Risk factors for mortality in geriatric hip fractures:a compressional study of different surgical procedures in785 consecutive patients. Eur J Orthop Surg Traumatol. 2017;27(1):101-106.
[7]Capdevila A, Navarro M, Bori G, et al. Incidence and Risk Factors for Infection When Teicoplanin Is Included for Prophylaxis in Patients with Hip Fracture. Surg Infect(Larchmt). 2016;17(4):381-384.
[8]Guo Y, Jia P, Zhang J, et al. Prevalence and risk factors of postoperative delirium in elderly hip fracture patients. J Int Med Res.2016;44(2):317-327.
[9]De Luca ML, Ciccarello M, Martorana M, et al. Pain monitoring and management in a rehabilitation setting after total joint replacement.Medicine(Baltimore). 2018;97(40):e12484.
[10]Katchy AU, Anyaehie UE, Nwadinigwe CU, et al. Total hip replacement in sickle cell disorder:a preliminary report of challenges and early outcome of 21 consecutive patients. Niger J Clin Pract. 2018;21(4):492-495.
[11]Li J, ke XJ, Liu Y, et al. The clinical application of lumbar plexus-the first posterior sacral foramina block for hip arthroplasty in elderly patients. Zhonghua Yi Xue Za Zhi. 2016;96(43):3470-3473.
[12]罗声臻,潘永英,盛福庭,等.超声引导髂筋膜腔隙与髂腹下/髂腹股沟神经复合阻滞在老年患者髋关节置换术术后镇痛中的作用[J].国际麻醉学与复苏杂志,2017,38(6):506-509,514.
[13]Mei B, Zha H, Lu X, et al. Peripheral nerve block as a supplement to light or deep general anesthesia in elderly patients receiving total hip arthroplasty:a prospective randomized study. Clin J Pain. 2017;33(12):1053-59.
[14]Ke X, Li J, Liu Y, et al. Surgical anesthesia with a combination of T12paravertebral block and lumbar plexus, sacral plexus block for hip replacement in ankylosing spondylitis:CARE-compliant 4 case reports.BMC Anesthesiol. 2017;17(1):86.
[15]Newman B, Mc Carthy L, Thomas PW, et al. A comparison of preoperative nerve stimulator-guided femoral nerve block and fascia iliacacompartment block in patients with a femoral neck fracture.Anaesthesia. 2013;68(9):899-903.
[16]Aksoy M, Dostbil A, Ince I, et al. Continuous spinal anaesthesia versus ultrasound-guided combined psoas compartment-sciatic nerve block for hip replacement surgery in elderly high-risk patients:a prospective randomised study. BMC Anesthesiol. 2014;14:99.
[17]Yu B, He M, Cai GY, et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly:a randomized controlled clinical trial(CONSORT). Medicine(Baltimore). 2016;95(42):e5056.
[18]Kuchálik J, Magnuson A, Tina E, et al. Does local infiltration analgesia reduce peri-operative inflammation following total hip arthroplasty? A randomized, double-blind study. BMC Anesthesiol. 2017;17(1):63.
[19]Liu Y, Ke X, Wu X, et al. Ultrasound-guided lumbar plexus block in supine position. Anesthesiology. 2018;128(4):812.
[20]张大志,常颖,杨庆国.超声引导下髂筋膜间隙不同角度多点阻滞与单点阻滞效果的比较[J].临床麻醉学杂志,2015,31(1):50-52.
[21]Flytstr?m I, Stenberg B, Svensson?, et al. Patients'visual analogue scale:a useful method for assessing psoriasis severity. Acta Derm Venereol. 2012;92(4):347-348.
[22]陆小龙,梅斌,陈士寿,等.超声引导下腰骶丛神经阻滞联合全麻在高龄患者髋关节置换术的临床应用[J].临床麻醉学杂志,2016,32(3):237-240.
[23]Karmakar MK, Li JW, Kwok WH, Hadzic A. Ultrasound-guided lumbar plexus block using a transverse scan through the lumbar intertransverse space:a prospective case series. Reg Anesth Pain Med 2015;40:75-81.
[24]Strid JMC, Sauter AR, Ullensvang K, et al. Ultrasound-guided lumbar plexus block in volunteers:a randomized controlled trial. Br J Anaesth.2017;118:430-438.
[25]Inan N, Akin Takmaz S, Iltar S, et al. The effects oftwo different multimodal analgesic regimens in total hip replacement surgery. Agri.2009;21(2):69-74.