CClinicalTrials.gg
RecruitingNCT03116490Updated Jul 24, 2024

The Effects of Anesthesia Type on the Prognosis of Hip Fracture Surgery on Elderly Patients

An observational study in Postoperative Complications and Postoperative Mortality, sponsored by Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Wenzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
60 Years and older
Sex
All
01

Study summary

The aim of this study is to figure out whether anesthesia type have an influence on the prognosis of hip fracture surgery.30-day mortality and morbidity after the surgery are our main observational index,and according to literature and our experience,regional anesthesia may have a better prognosis after hip fracture surgery compared with general anesthesia.

Read the detailed description

Hip fracture is a common disease among elderly people,and has a high mortality and morbidity.But,seldom practice can be done to improve this condition.For a long time,whether anesthesia type could influence the prognosis after surgery is controversial.Several studies have confirmed regional anesthesia may be better for patients for its fewer complications.But most studies are retrospective,and information may be less convincing .Besides,as a matter of fact,patients of different anesthesia type may have different status,so,a scoring system may be need for comparing the status of patients of different groups.

Our study is a prospective observational trial.Patients needing hip fracture surgery are divided into two groups according to the anesthesia type during surgery:Regional Anesthesia group(RA),General Anesthesia group(GA).To evaluate the status of patients before surgery,we use Orthopedic POSSUM scoring system.It consists of 12 physiological factors and 6 operative severity factors.Then,we will observe outcome of the two groups and record every complication after surgery.Finally,the initial and adjusted morbidity and mortality according to Orthopedic POSSUM scoring system of the two groups are compared.

02

Conditions studied

  • Postoperative Complications
  • Postoperative Mortality

Keywords

  • morbidity
  • mortality
  • hip fracture
  • anesthesia type
  • POSSUM
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

elderly patients experiencing hip fracture surgery.

Inclusion criteria

  • Patients with hip fracture;
  • Need surgery;
  • Anesthesia type is regional anesthesia or general anesthesia;
  • Age≥60 years.

Exclusion criteria

Exclusion Criteria:

  • Choosing conservative treatment;
  • Other types of anesthesia or without anesthesia.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • group RA

    the anesthesia type for patients with hip fracture surgery is regional anesthesia

    Procedure: Anesthesia type

  • group GA

    the anesthesia type for patients with hip fracture surgery is general anesthesia

    Procedure: Anesthesia type

Interventions

  • ProcedureAnesthesia type

    RA group uses regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) ,and GA group uses general anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) .

05

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 30-day after surgery

Secondary outcomes

  1. Morbidity

    Time frame: 30-day after surgery

  2. VAS pain score

    Time frame: everyday after surgery,record for 7 days

Other outcomes

  1. The Orthopedic POSSUM score

    Time frame: baseline

06

Study locations

1 of 1 sites recruiting
  • WenZhou Medical University Second Affiliated Hospital
    WenZhou, Zhejiang 325000, China
    Recruiting
07

References and documents

Publications

  • Radcliff TA, Henderson WG, Stoner TJ, Khuri SF, Dohm M, Hutt E. Patient risk factors, operative care, and outcomes among older community-dwelling male veterans with hip fracture. J Bone Joint Surg Am. 2008 Jan;90(1):34-42. doi: 10.2106/JBJS.G.00065. PubMed 18171955 ↗
  • Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16. PubMed 16983459 ↗
  • Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462. PubMed 19826027 ↗
  • Parker M, Johansen A. Hip fracture. BMJ. 2006 Jul 1;333(7557):27-30. doi: 10.1136/bmj.333.7557.27. No abstract available. PubMed 16809710 ↗
  • Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR. Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005 Nov;20(11):1019-25. doi: 10.1111/j.1525-1497.2005.00219.x. PubMed 16307627 ↗
  • Neuman MD, Archan S, Karlawish JH, Schwartz JS, Fleisher LA. The relationship between short-term mortality and quality of care for hip fracture: a meta-analysis of clinical pathways for hip fracture. J Am Geriatr Soc. 2009 Nov;57(11):2046-54. doi: 10.1111/j.1532-5415.2009.02492.x. Epub 2009 Sep 28. PubMed 19793159 ↗
  • Vestergaard P, Rejnmark L, Mosekilde L. Loss of life years after a hip fracture. Acta Orthop. 2009 Oct;80(5):525-30. doi: 10.3109/17453670903316835. PubMed 19916683 ↗
  • Vochteloo AJ, Borger van der Burg BL, Roling MA, van Leeuwen DH, van den Berg P, Niggebrugge AH, de Vries MR, Tuinebreijer WE, Bloem RM, Nelissen RG, Pilot P. Contralateral hip fractures and other osteoporosis-related fractures in hip fracture patients: incidence and risk factors. An observational cohort study of 1,229 patients. Arch Orthop Trauma Surg. 2012 Aug;132(8):1191-7. doi: 10.1007/s00402-012-1520-9. Epub 2012 Apr 24. PubMed 22526197 ↗
  • Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2001;(4):CD000521. doi: 10.1002/14651858.CD000521. PubMed 11687085 ↗
  • O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011. PubMed 10754613 ↗
  • Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493. PubMed 11118174 ↗
  • Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c. PubMed 22713634 ↗
  • Neuman MD, Rosenbaum PR, Ludwig JM, Zubizarreta JR, Silber JH. Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA. 2014 Jun 25;311(24):2508-17. doi: 10.1001/jama.2014.6499. PubMed 25058085 ↗
  • Patorno E, Neuman MD, Schneeweiss S, Mogun H, Bateman BT. Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. BMJ. 2014 Jun 27;348:g4022. doi: 10.1136/bmj.g4022. PubMed 24972901 ↗
  • Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978 Oct;49(4):239-43. doi: 10.1097/00000542-197810000-00003. PubMed 697077 ↗
  • Copeland GP, Jones D, Walters M. POSSUM: a scoring system for surgical audit. Br J Surg. 1991 Mar;78(3):355-60. doi: 10.1002/bjs.1800780327. PubMed 2021856 ↗
  • Brunelli A, Fianchini A, Xiume F, Gesuita R, Mattei A, Carle F. Evaluation of the POSSUM scoring system in lung surgery. Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity. Thorac Cardiovasc Surg. 1998 Jun;46(3):141-6. doi: 10.1055/s-2007-1010211. PubMed 9714489 ↗
  • Gotohda N, Iwagaki H, Itano S, Horiki S, Fujiwara T, Saito S, Hizuta A, Isozaki H, Takakura N, Terada N, Tanaka N. Can POSSUM, a scoring system for perioperative surgical risk, predict postoperative clinical course? Acta Med Okayama. 1998 Dec;52(6):325-9. doi: 10.18926/AMO/31304. PubMed 9876770 ↗
  • Tekkis PP, Kocher HM, Bentley AJ, Cullen PT, South LM, Trotter GA, Ellul JP. Operative mortality rates among surgeons: comparison of POSSUM and p-POSSUM scoring systems in gastrointestinal surgery. Dis Colon Rectum. 2000 Nov;43(11):1528-32, discusssion 1532-4. doi: 10.1007/BF02236732. PubMed 11089587 ↗
  • Mohamed K, Copeland GP, Boot DA, Casserley HC, Shackleford IM, Sherry PG, Stewart GJ. An assessment of the POSSUM system in orthopaedic surgery. J Bone Joint Surg Br. 2002 Jul;84(5):735-9. doi: 10.1302/0301-620x.84b5.12626. PubMed 12188495 ↗
  • Wright DM, Blanckley S, Stewart GJ, Copeland GP. The use of orthopaedic POSSUM as an audit tool for fractured neck of femur. Injury. 2008 Apr;39(4):430-5. doi: 10.1016/j.injury.2007.11.009. Epub 2008 Mar 7. PubMed 18316084 ↗
  • OVERALL JE, WILLIAMS CM. Models for medical diagnosis. Behav Sci. 1961 Apr;6:134-41. doi: 10.1002/bs.3830060205. No abstract available. PubMed 13731759 ↗
08

Registry details

Key details

Study ID
NCT03116490
Lead sponsor
Wenzhou Medical University
Responsible party
Ting Li (Director,Associate chief physician of Anesthesia Department, Wenzhou Medical University) — Principal investigator
First posted
Apr 17, 2017
Start date
Jan 16, 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 24, 2024

Study contacts

Ting Li, M.D.
Contact
liting1021@aliyun.com
00447570150148
Yahe Ge, Medical Student
Contact
770736428@qq.com
008615330056542
Ting Li, M.D.
study chair · The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Yahe Ge, Medical Student
principal investigator · The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion