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

Postoperative Complications Clinical Trial

Official title:

The Comparative Effects of Regional or General Anesthesia on the Prognosis of Hip Fracture Surgery on Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03116490
• Other study ID #: RAGA-PHP
• Status: Recruiting
• Start date: January 16, 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Wenzhou Medical University
• Contact: Ting Li, M.D.
• Phone: 00447570150148
• Email: liting1021[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients with hip fracture;

• Need surgery;

• Anesthesia type is regional anesthesia or general anesthesia;

• Age=60 years.

Exclusion Criteria:

• Choosing conservative treatment;

• Other types of anesthesia or without anesthesia.

Related Conditions & MeSH terms

• Hip Fractures
• Postoperative Complications
• Postoperative Mortality

Intervention

Procedure:
• Anesthesia 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) .

Locations

Country	Name	City	State
China	WenZhou Medical University Second Affiliated Hospital	WenZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (22)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Copeland GP, Jones D, Walters M. POSSUM: a scoring system for surgical audit. Br J Surg. 1991 Mar;78(3):355-60. — View Citation

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. — View Citation

Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. Epub 2006 Sep 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978 Oct;49(4):239-43. — View Citation

Parker M, Johansen A. Hip fracture. BMJ. 2006 Jul 1;333(7557):27-30. Review. — View Citation

Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2001;(4):CD000521. Review. Update in: Cochrane Database Syst Rev. 2004;(4):CD000521. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Vochteloo AJ, Borger van der Burg BL, Röling 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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Orthopedic POSSUM score		baseline
Primary	Mortality		30-day after surgery
Secondary	Morbidity		30-day after surgery
Secondary	VAS pain score		everyday after surgery,record for 7 days

External Links

•   The second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University