Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial

Junfeng Zhang, Xiaofeng Wang, Hui Zhang, Zhuolin Shu, Wei Jiang, Junfeng Zhang, Xiaofeng Wang, Hui Zhang, Zhuolin Shu, Wei Jiang

Abstract

Introduction: Hip fracture in elderly people is a global public health problem, with substantial associated mortality and disability. Nearly all patients with hip fracture undergo surgical treatment, but optimal anaesthesia for hip fracture surgery in elderly patients is still inconclusive. Ultrasound-guided combined lumbar and sacral plexus block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients. However, it is not clear whether it can improve the postoperative outcomes of elderly patients with hip fracture.

Method and analysis: This research project is a two-arm, parallel, multicentre, prospective randomised controlled trail. A total of 1086 patients aged 75 and older scheduled for hip fracture surgery in five clinical trial centres of China will be randomised in a 1:1 ratio to receive either combined lumbar and sacral plexus block plus sedation or general anaesthesia. The primary outcome will be the postoperative 1-year all-cause mortality. The secondary outcomes will be the incidence of postoperative complications, high-sensitivity cardiac troponin T, early mobility after surgery, postoperative Visual Analogue Scale pain scores, postoperative delirium, length of stay in intensive care unit and hospital, cost-effective outcomes, Barthel Index and incidence of adverse events after discharge. Assessments will be conducted in four steps: preoperative, intraoperative, in-hospital data collection and post-discharge telephone follow-up.

Ethics and dissemination: This study has been supported by Shanghai Municipal Commission of Health and Family Planning Foundation for Key Developing Disciplines (2015ZB0103) and approved by the Ethics Committee of Shanghai Sixth People's Hospital [No: 2016-28-(2)]. At the time of manuscript submission, the protocol version is V.1.6 (March 2nd, 2018) with one subsequent approved amendment. Results will be disseminated via an international peer-reviewed publication.

Trial registration number: NCT03318133.

Keywords: elderly; general anaesthesia; hip fracture; lumbar plexus block; sacral plexus block.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials flowchart designed for subject enrolment. CSLB, combined lumbar-sacral plexus block; GA, general anesthesia; LMA, laryngeal mask airway.

References

    1. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726–33. 10.1007/s00198-006-0172-4
    1. Cooper C, Campion G, Melton LJ. Hip fractures in the elderly: a world-wide projection. Osteoporos Int 1992;2:285–9. 10.1007/BF01623184
    1. Brauer CA, Coca-Perraillon M, Cutler DM, et al. . Incidence and mortality of hip fractures in the United States. JAMA 2009;302:1573–9. 10.1001/jama.2009.1462
    1. Roche JJ, Wenn RT, Sahota O, et al. . Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ 2005;331:1374 10.1136/bmj.38643.663843.55
    1. Lawrence VA, Hilsenbeck SG, Noveck H, et al. . Medical complications and outcomes after hip fracture repair. Arch Intern Med 2002;162:2053–7. 10.1001/archinte.162.18.2053
    1. Guay J, Parker MJ, Gajendragadkar PR, et al. . Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev 2016;2:Cd000521 10.1002/14651858.CD000521.pub3
    1. Memtsoudis SG, Sun X, Chiu YL, et al. . Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology 2013;118:1046–58. 10.1097/ALN.0b013e318286061d
    1. Neuman MD, Silber JH, Elkassabany NM, et al. . Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology 2012;117:72–92. 10.1097/ALN.0b013e3182545e7c
    1. Patorno E, Neuman MD, Schneeweiss S, et al. . Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. BMJ 2014;348:g4022 10.1136/bmj.g4022
    1. Neuman MD, Rosenbaum PR, Ludwig JM, et al. . Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA 2014;311:2508–17. 10.1001/jama.2014.6499
    1. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia 2014;69:224–30. 10.1111/anae.12542
    1. Gamli M, Sacan O, Baskan S, et al. . Combined lumbar plexus and sciatic nerve block for hip fracture surgery in a patient with severe aortic stenosis. J Anesth 2011;25:784–5. 10.1007/s00540-011-1179-3
    1. Ho AM, Karmakar MK. Combined paravertebral lumbar plexus and parasacral sciatic nerve block for reduction of hip fracture in a patient with severe aortic stenosis. Can J Anaesth 2002;49:946–50. 10.1007/BF03016880
    1. Karaca S, Ayhan E, Kesmezacar H, et al. . Hip fracture mortality: is it affected by anesthesia techniques? Anesthesiol Res Pract 2012;2012:1–5. 10.1155/2012/708754
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 10.1136/bmj.e7586
    1. Karademir G, Bilgin Y, Erşen A, et al. . Hip fractures in patients older than 75 years old: Retrospective analysis for prognostic factors. Int J Surg 2015;24(Pt A):101–4. 10.1016/j.ijsu.2015.11.009
    1. Carson JL, Terrin ML, Noveck H, et al. . Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med 2011;365:2453–62. 10.1056/NEJMoa1012452
    1. Slankamenac K, Nederlof N, Pessaux P, et al. . The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg 2014;260:757–62. 10.1097/SLA.0000000000000948
    1. Inouye SK, van Dyck CH, Alessi CA, et al. . Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med 1990;113:941–8.
    1. Ferreira FL, Bota DP, Bross A, et al. . Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001;286:1754–8. 10.1001/jama.286.14.1754
    1. Bauer M, Böhrer H, Aichele G, et al. . Measuring patient satisfaction with anaesthesia: perioperative questionnaire versus standardised face-to-face interview. Acta Anaesthesiol Scand 2001;45:65–72. 10.1034/j.1399-6576.2001.450111.x
    1. Cox DR. Regression Models and Life-Tables. J Royal Stat Soc 1992;34:187–220.
    1. Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics 1983;39:499–503. 10.2307/2531021
    1. Singelyn FJ, Ferrant T, Malisse MF, et al. . Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med 2005;30:452–7. 10.1097/00115550-200509000-00006

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe