- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116490
The Effects of Anesthesia Type on the Prognosis of Hip Fracture Surgery on Elderly Patients
The Comparative Effects of Regional or General Anesthesia on the Prognosis of Hip Fracture Surgery on Elderly Patients
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yahe Ge, Medical Student
- Phone Number: 008615330056542
- Email: 770736428@qq.com
Study Contact Backup
- Name: Ting Li, M.D.
- Phone Number: 00447570150148
- Email: liting1021@aliyun.com
Study Locations
-
-
Zhejiang
-
WenZhou, Zhejiang, China, 325000
- Recruiting
- WenZhou Medical University Second Affiliated Hospital
-
Contact:
- Yahe Ge, Medical Student
- Phone Number: 008615330056542
- Email: 770736428@qq.com
-
Contact:
- Ting Li, M.D.
- Phone Number: 00447570150148
- Email: liting1021@aliyun.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group RA
the anesthesia type for patients with hip fracture surgery is regional anesthesia
|
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) .
|
|
group GA
the anesthesia type for patients with hip fracture surgery is general anesthesia
|
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) .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality
Time Frame: 30-day after surgery
|
30-day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Morbidity
Time Frame: 30-day after surgery
|
30-day after surgery
|
|
VAS pain score
Time Frame: everyday after surgery,record for 7 days
|
everyday after surgery,record for 7 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Orthopedic POSSUM score
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ting Li, M.D., The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
- Principal Investigator: Yahe Ge, Medical Student, The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Parker M, Johansen A. Hip fracture. BMJ. 2006 Jul 1;333(7557):27-30. doi: 10.1136/bmj.333.7557.27. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- OVERALL JE, WILLIAMS CM. Models for medical diagnosis. Behav Sci. 1961 Apr;6:134-41. doi: 10.1002/bs.3830060205. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAGA-PHP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complications
-
Twin Cities Spine CenterAllina Health SystemRecruitingComplications, PostoperativeUnited States
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainCompletedComplications, PostoperativeUnited States
-
Yale UniversityRecruitingPostoperative Complications (Cardiopulmonary)United States
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Chi Mei Medical HospitalCompletedPostoperative Respiratory Complications | Pain, Postoperative.Taiwan
-
Fujian Medical University Union HospitalNot yet recruitingPostoperative Pulmonary Complications
-
COPAL - My JourneyRecruiting
Clinical Trials on Anesthesia type
-
Sevim Şenol KarataşCompletedNephrolithiasis | Postoperative InflammationTurkey (Türkiye)
-
Charitable Organisation Charitable Fund Superhumans...Not yet recruitingPain | Pain Management | Phantom Limb Pain | Phantom Limb Pain After AmputationUkraine
-
Central Hospital, Nancy, FranceUnknownDelirium | Aortic Valve Disease | Anesthesia | Post-Op ComplicationFrance
-
Institut d'Investigació Biomèdica de Girona Dr....CompletedGeneral Anesthesia | Conscious Sedation | Mechanical Thrombectomy | Posterior CirculationSpain
-
Vittore Buzzi Children's HospitalCompletedPediatric Anesthesia | AtelectasisItaly
-
Kaiser PermanenteCompletedOsteoarthritis, Knee | Anesthesia Morbidity | Osteoarthritis, HipUnited States
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruiting
-
Gaziantep City HospitalNot yet recruiting
-
Tanta UniversityCompletedSpinal Anesthesia | General Anesthesia | Adults | Cystoscope | Penile LengthEgypt
-
University of ZagrebActive, not recruiting