Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

NCT02507505 | Completed Results DMC

• 2 other identifiers: 822632PCORI-1406-18876
• Study Type: interventional
• Target: 1,848
• Locations: 2 countries
• Sites: 45

Brief Summary

The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance

  Will be assessed via telephone interview

  Approximately 60 days after Randomization

Secondary Outcomes (11)

• Overall Health and Disability

  Approximately 60, 180, and 365 days after randomization

• Ability to Return to Home

  Approximately 60, 180, and 365 days after randomization

• Chronic Pain

  Approximately 60, 180, and 365 days after randomization

• Cognitive Function

  Baseline and approximately 60, 180, and 365 days after randomization

• All-cause Mortality

  Approximately 60, 180, and 365 days after randomization

Study Arms (2)

Regional Anesthesia

ACTIVE COMPARATOR

Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia.

Procedure: Regional Anesthesia

General Anesthesia

ACTIVE COMPARATOR

Approximately half of the subjects will be randomized to the arm which receives General Anesthesia.

Procedure: General Anesthesia

Interventions

Regional Anesthesia PROCEDURE

Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.

Also known as: Regional Block or Spinal Block

Regional Anesthesia

General Anesthesia PROCEDURE

General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.

Also known as: General Endotracheal Anesthesia

General Anesthesia

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
• Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
• Ability to walk 10 feet or across a room without human assistance before fracture

You may not qualify if:

• Planned concurrent surgery not amenable to spinal anesthesia
• Absolute contraindications to spinal anesthesia
• Periprosthetic fracture

Sponsors & Collaborators

• University of Pennsylvania: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (45)

University of Alabama Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

University of Florida Gainesville

Gainesville, Florida, 32608, United States

Location

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

Florida Hospital

Winter Park, Florida, 32792, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospital & Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Rutgers-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

NYU-Winthrop Hospital

Mineola, New York, 11501, United States

Location

NYU Langone Medical Center

New York, New York, 10003, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Sacred Heart at RiverBend

Springfield, Oregon, 97477, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Reading Hospital

Reading, Pennsylvania, 19611, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University Medical Center Brackenridge and Seton Medical Center Williamson

Austin, Texas, 78705, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Inova Fairfax Medical Campus

Fairfax, Virginia, 22042, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Simon Fraser Orthopaedic Fund - Royal Columbian Hospital

New Westminster, British Columbia, V3L 3M2, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Publications (5)

• Clapp JT, Dinh C, Hsu M, Neuman MD. Clinical reasoning in pragmatic trial randomization: a qualitative interview study. Trials. 2023 Jun 27;24(1):431. doi: 10.1186/s13063-023-07445-3.

  PMID: 37365614 DERIVED

• Neuman MD, Feng R, Ellenberg SS, Sieber F, Sessler DI, Magaziner J, Elkassabany N, Schwenk ES, Dillane D, Marcantonio ER, Menio D, Ayad S, Hassan M, Stone T, Papp S, Donegan D, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes R, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Tierney A, Gaskins LJ, Horan AD, Brown T, Dattilo J, Carson JL; REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) Investigators*; Looke T, Bent S, Franco-Mora A, Hedrick P, Newbern M, Tadros R, Pealer K, Vlassakov K, Buckley C, Gavin L, Gorbatov S, Gosnell J, Steen T, Vafai A, Zeballos J, Hruslinski J, Cardenas L, Berry A, Getchell J, Quercetti N, Bajracharya G, Billow D, Bloomfield M, Cuko E, Elyaderani MK, Hampton R, Honar H, Khoshknabi D, Kim D, Krahe D, Lew MM, Maheshwer CB, Niazi A, Saha P, Salih A, de Swart RJ, Volio A, Bolkus K, DeAngelis M, Dodson G, Gerritsen J, McEniry B, Mitrev L, Kwofie MK, Belliveau A, Bonazza F, Lloyd V, Panek I, Dabiri J, Chavez C, Craig J, Davidson T, Dietrichs C, Fleetwood C, Foley M, Getto C, Hailes S, Hermes S, Hooper A, Koener G, Kohls K, Law L, Lipp A, Losey A, Nelson W, Nieto M, Rogers P, Rutman S, Scales G, Sebastian B, Stanciu T, Lobel G, Giampiccolo M, Herman D, Kaufman M, Murphy B, Pau C, Puzio T, Veselsky M, Apostle K, Boyer D, Fan BC, Lee S, Lemke M, Merchant R, Moola F, Payne K, Perey B, Viskontas D, Poler M, D'Antonio P, O'Neill G, Abdullah A, Fish-Fuhrmann J, Giska M, Fidkowski C, Guthrie ST, Hakeos W, Hayes L, Hoegler J, Nowak K, Beck J, Cuff J, Gaski G, Haaser S, Holzman M, Malekzadeh AS, Ramsey L, Schulman J, Schwartzbach C, Azefor T, Davani A, Jaberi M, Masear C, Haider SB, Chungu C, Ebrahimi A, Fikry K, Marcantonio A, Shelvan A, Sanders D, Clarke C, Lawendy A, Schwartz G, Garg M, Kim J, Caruci J, Commeh E, Cuevas R, Cuff G, Franco L, Furgiuele D, Giuca M, Allman M, Barzideh O, Cossaro J, D'Arduini A, Farhi A, Gould J, Kafel J, Patel A, Peller A, Reshef H, Safur M, Toscano F, Tedore T, Akerman M, Brumberger E, Clark S, Friedlander R, Jegarl A, Lane J, Lyden JP, Mehta N, Murrell MT, Painter N, Ricci W, Sbrollini K, Sharma R, Steel PAD, Steinkamp M, Weinberg R, Wellman DS, Nader A, Fitzgerald P, Ritz M, Bryson G, Craig A, Farhat C, Gammon B, Gofton W, Harris N, Lalonde K, Liew A, Meulenkamp B, Sonnenburg K, Wai E, Wilkin G, Troxell K, Alderfer ME, Brannen J, Cupitt C, Gerhart S, McLin R, Sheidy J, Yurick K, Chen F, Dragert K, Kiss G, Malveaux H, McCloskey D, Mellender S, Mungekar SS, Noveck H, Sagebien C, Biby L, McKelvy G, Richards A, Abola R, Ayala B, Halper D, Mavarez A, Rizwan S, Choi S, Awad I, Flynn B, Henry P, Jenkinson R, Kaustov L, Lappin E, McHardy P, Singh A, Donnelly J, Gonzalez M, Haydel C, Livelsberger J, Pazionis T, Slattery B, Vazquez-Trejo M, Baratta J, Cirullo M, Deiling B, Deschamps L, Glick M, Katz D, Krieg J, Lessin J, Mojica J, Torjman M, Jin R, Salpeter MJ, Powell M, Simmons J, Lawson P, Kukreja P, Graves S, Sturdivant A, Bryant A, Crump SJ, Verrier M, Green J, Menon M, Applegate R, Arias A, Pineiro N, Uppington J, Wolinsky P, Gunnett A, Hagen J, Harris S, Hollen K, Holloway B, Horodyski MB, Pogue T, Ramani R, Smith C, Woods A, Warrick M, Flynn K, Mongan P, Ranganath Y, Fernholz S, Ingersoll-Weng E, Marian A, Seering M, Sibenaller Z, Stout L, Wagner A, Walter A, Wong C, Orwig D, Goud M, Helker C, Mezenghie L, Montgomery B, Preston P, Schwartz JS, Weber R, Fleisher LA, Mehta S, Stephens-Shields AJ, Dinh C, Chelly JE, Goel S, Goncz W, Kawabe T, Khetarpal S, Monroe A, Shick V, Breidenstein M, Dominick T, Friend A, Mathews D, Lennertz R, Sanders R, Akere H, Balweg T, Bo A, Doro C, Goodspeed D, Lang G, Parker M, Rettammel A, Roth M, White M, Whiting P, Allen BFS, Baker T, Craven D, McEvoy M, Turnbo T, Kates S, Morgan M, Willoughby T, Weigel W, Auyong D, Fox E, Welsh T, Cusson B, Dobson S, Edwards C, Harris L, Henshaw D, Johnson K, McKinney G, Miller S, Reynolds J, Segal BS, Turner J, VanEenenaam D, Weller R, Lei J, Treggiari M, Akhtar S, Blessing M, Johnson C, Kampp M, Kunze K, O'Connor M, Looke T, Tadros R, Vlassakov K, Cardenas L, Bolkus K, Mitrev L, Kwofie MK, Dabiri J, Lobel G, Poler M, Giska M, Sanders D, Schwartz G, Giuca M, Tedore T, Nader A, Bryson G, Troxell K, Kiss G, Choi S, Powell M, Applegate R, Warrick M, Ranganath Y, Chelly JE, Lennertz R, Sanders R, Allen BFS, Kates S, Weigel W, Li J, Wijeysundera DN, Kheterpal S, Moore RH, Smith AK, Tosi LL, Looke T, Mehta S, Fleisher L, Hruslinski J, Ramsey L, Langlois C, Mezenghie L, Montgomery B, Oduwole S, Rose T; REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) Investigators. Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial. Ann Intern Med. 2022 Jul;175(7):952-960. doi: 10.7326/M22-0320. Epub 2022 Jun 14.

  PMID: 35696684 DERIVED

• Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.

  PMID: 34623788 DERIVED

• Neuman MD, Gaskins LJ, Ziolek T; REGAIN Investigators. Time to institutional review board approval with local versus central review in a multicenter pragmatic trial. Clin Trials. 2018 Feb;15(1):107-111. doi: 10.1177/1740774517735536. Epub 2017 Oct 6.

  PMID: 28982261 DERIVED

• Neuman MD, Ellenberg SS, Sieber FE, Magaziner JS, Feng R, Carson JL; REGAIN Investigators. Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial. BMJ Open. 2016 Nov 15;6(11):e013473. doi: 10.1136/bmjopen-2016-013473.

  PMID: 27852723 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, Conduction; Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Mark D. Neuman, MD, MSc (Principal Investigator)
• Organization: University of Pennsylvania Perelman School of Medicine

mark.neuman@uphs.upenn.edu

215-746-7468

Study Officials

• Mark D Neuman, MD, MSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 24, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2023-12

Locations

US (38); CA (7)