Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Conditions

Hip Fractures

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.

Detailed description

Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide. Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery. No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia, making the anesthetic care episode a major opportunity to impact outcomes. Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice. REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice. Approximately 2,424 subjects will be enrolled (i.e. informed consent for participation will be obtained) in order to yield approximately 1,600 randomized patients. This estimate is based on an assumption that one in three patients (33%) who undergo consent prior to surgery will not be randomized on the day of surgery due to active clinical issues, timing of medication dosing, clinical assessments by treating physicians or the site Clinical Director or their designate, or patient withdrawal of consent.

Clapp JT, Dinh C, Hsu M, Neuman MD.

2023-06-272 citations

10.1186/s13063-023-07445-3

Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial.

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.

2022-06-1436 citations

10.7326/m22-0320

Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults

Mark D. Neuman, Rui Feng, Jeffrey L. Carson, Lakisha J. Gaskins, Derek Dillane et al. (44 authors)

New England Journal of Medicine2021-10-10419 citations

10.1056/nejmoa2113514

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia

Ana Kowark, Christian Adam, Jörg Ahrens, Malek Bajbouj, Cornelius Bollheimer et al. (37 authors)

BMJ Open2018-10-0156 citations

10.1136/bmjopen-2018-023609

Time to institutional review board approval with local versus central review in a multicenter pragmatic trial.

Neuman MD, Gaskins LJ, Ziolek T, REGAIN Investigators.

2017-10-0613 citations

10.1177/1740774517735536

Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial

Mark D. Neuman, Susan S. Ellenberg, Frederick E. Sieber, Jay Magaziner, Rui Feng et al. (6 authors)

BMJ Open2016-11-0187 citations

10.1136/bmjopen-2016-013473

Interventions

PROCEDURERegional Anesthesia

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.

PROCEDUREGeneral Anesthesia

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance	Approximately 60 days after Randomization	Will be assessed via telephone interview

Secondary

Measure	Time frame	Description
Ability to Return to Home	Approximately 60, 180, and 365 days after randomization	Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point.
Chronic Pain	Approximately 60, 180, and 365 days after randomization	Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain.
Cognitive Function	Baseline and approximately 60, 180, and 365 days after randomization	Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment.
All-cause Mortality	Approximately 60, 180, and 365 days after randomization	Will be assessed via telephone interview and National Death Index (NDI) search
Need for Assistive Devices for Walking	Approximately 60, 180, and 365 days after randomization	Will be assessed via telephone interview
Overall Health and Disability	Approximately 60, 180, and 365 days after randomization	Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability.
Satisfaction With Care	Postoperative day 3 or day of discharge, whichever occurs first	Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of dissatisfied or very dissatisfied to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general.
Postoperative Delirium	Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first	Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium.
Inpatient Mortality	During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first	Will be assessed via medical chart review. Data reported here on inpatient mortality.
Major Inpatient Morbidity	During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first	Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury.
Acute Postoperative Pain	Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first	Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain.

Countries

Canada, United States

Participant flow

Pre-assignment details

Of the 1848 participants who provided informed consent, 248 withdrew consent prior to randomization; 1600 participants were randomly assigned to a treatment group and continued in the study.

Participants by arm

Arm	Count
Regional Anesthesia Approximately half of the subjects will be randomized to the arm which receives Regional Anesthesia. Regional Anesthesia: 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.	795
General Anesthesia Approximately half of the subjects will be randomized to the arm which receives General Anesthesia. General Anesthesia: 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.	805
Total	1,600

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death before receipt of anesthesia	0	1
Overall Study	Participant contacted but walking status was unknown	14	16
Overall Study	Participant unable to be contacted within 60-day interview window	56	44
Overall Study	Withdrawal by Subject	13	11

Baseline characteristics

Characteristic	Total	General Anesthesia	Regional Anesthesia
3D-CAM Assessment for Delirium	200 Participants	104 Participants	96 Participants
Age, Continuous	78.1 years STANDARD_DEVIATION 10.7	78.4 years STANDARD_DEVIATION 10.6	77.7 years STANDARD_DEVIATION 10.7
Race/Ethnicity, Customized Black	122 Participants	67 Participants	55 Participants
Race/Ethnicity, Customized Hispanic ethnic group	27 Participants	12 Participants	15 Participants
Race/Ethnicity, Customized Other or more than one race	40 Participants	16 Participants	24 Participants
Race/Ethnicity, Customized White	1374 Participants	691 Participants	683 Participants
Region of Enrollment Canada	422 participants	212 participants	210 participants
Region of Enrollment United States	1178 participants	593 participants	585 participants
Sex: Female, Male Female	1072 Participants	535 Participants	537 Participants
Sex: Female, Male Male	528 Participants	270 Participants	258 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	98 / 795	92 / 805
other Total, other adverse events	278 / 795	286 / 805
serious Total, serious adverse events	255 / 795	242 / 805

Outcome results

Primary

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

Will be assessed via telephone interview

Time frame: Approximately 60 days after Randomization

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance	132 Participants
General Anesthesia	Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance	132 Participants

Secondary

Ability to Return to Home

Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point.

Time frame: Approximately 60, 180, and 365 days after randomization

Population: This outcome was assessed among patients who were not admitted from a nursing home, rehabilitation facility, or acute care hospital. Denominator includes all known decedents at each time point, plus survivors providing information on location of residence at the time of study interview.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Ability to Return to Home	365-day outcomes	119 Participants
Regional Anesthesia	Ability to Return to Home	60-day outcomes	108 Participants
Regional Anesthesia	Ability to Return to Home	180-day outcomes	103 Participants
General Anesthesia	Ability to Return to Home	365-day outcomes	116 Participants
General Anesthesia	Ability to Return to Home	60-day outcomes	114 Participants
General Anesthesia	Ability to Return to Home	180-day outcomes	90 Participants

Secondary

Acute Postoperative Pain

Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain.

Time frame: Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first

Arm	Measure	Group	Value (MEAN)	Dispersion
Regional Anesthesia	Acute Postoperative Pain	Postoperative day 2	7.1 units on a scale	Standard Deviation 2.7
Regional Anesthesia	Acute Postoperative Pain	Postoperative day 3	6.8 units on a scale	Standard Deviation 2.9
Regional Anesthesia	Acute Postoperative Pain	Postoperative day 1	7.9 units on a scale	Standard Deviation 2.6
General Anesthesia	Acute Postoperative Pain	Postoperative day 1	7.6 units on a scale	Standard Deviation 2.8
General Anesthesia	Acute Postoperative Pain	Postoperative day 2	7.1 units on a scale	Standard Deviation 2.8
General Anesthesia	Acute Postoperative Pain	Postoperative day 3	6.6 units on a scale	Standard Deviation 3

Secondary

All-cause Mortality

Will be assessed via telephone interview and National Death Index (NDI) search

Time frame: Approximately 60, 180, and 365 days after randomization

Population: All enrolled patients who had not withdrawn or been lost to follow up a given study time point

Arm	Measure	Group	Value (NUMBER)
Regional Anesthesia	All-cause Mortality	60-day outcomes	30 participants
Regional Anesthesia	All-cause Mortality	180-day outcomes	69 participants
Regional Anesthesia	All-cause Mortality	365-day outcomes	98 participants
General Anesthesia	All-cause Mortality	60-day outcomes	32 participants
General Anesthesia	All-cause Mortality	180-day outcomes	63 participants
General Anesthesia	All-cause Mortality	365-day outcomes	92 participants

Secondary

Chronic Pain

Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain.

Time frame: Approximately 60, 180, and 365 days after randomization

Population: Numbers differ across rows due to missing data

Arm	Measure	Group	Value (MEAN)	Dispersion
Regional Anesthesia	Chronic Pain	60-day measure	4.5 units on a scale	Standard Deviation 3.2
Regional Anesthesia	Chronic Pain	180-day measure	3.5 units on a scale	Standard Deviation 3.3
Regional Anesthesia	Chronic Pain	365-day measure	3.1 units on a scale	Standard Deviation 3.2
General Anesthesia	Chronic Pain	60-day measure	4.2 units on a scale	Standard Deviation 3.2
General Anesthesia	Chronic Pain	180-day measure	3.4 units on a scale	Standard Deviation 3.3
General Anesthesia	Chronic Pain	365-day measure	3.2 units on a scale	Standard Deviation 3.3

Secondary

Cognitive Function

Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment.

Time frame: Baseline and approximately 60, 180, and 365 days after randomization

Population: Numbers differ across rows due to missing data

Arm	Measure	Group	Value (MEDIAN)
Regional Anesthesia	Cognitive Function	60 day measure	2 units on a scale
Regional Anesthesia	Cognitive Function	180 day measure	2 units on a scale
Regional Anesthesia	Cognitive Function	365 day measure	2 units on a scale
General Anesthesia	Cognitive Function	60 day measure	2 units on a scale
General Anesthesia	Cognitive Function	180 day measure	2 units on a scale
General Anesthesia	Cognitive Function	365 day measure	2 units on a scale

Secondary

Inpatient Mortality

Will be assessed via medical chart review. Data reported here on inpatient mortality.

Time frame: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Inpatient Mortality	5 Participants
General Anesthesia	Inpatient Mortality	13 Participants

Secondary

Major Inpatient Morbidity

Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury.

Time frame: During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Major Inpatient Morbidity	98 Participants
General Anesthesia	Major Inpatient Morbidity	120 Participants

Secondary

Need for Assistive Devices for Walking

Will be assessed via telephone interview

Time frame: Approximately 60, 180, and 365 days after randomization

Population: 60-day outcome

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Need for Assistive Devices for Walking	60 day outcomes	403 Participants
Regional Anesthesia	Need for Assistive Devices for Walking	180 day outcomes	231 Participants
Regional Anesthesia	Need for Assistive Devices for Walking	365 day outcomes	196 Participants
General Anesthesia	Need for Assistive Devices for Walking	60 day outcomes	397 Participants
General Anesthesia	Need for Assistive Devices for Walking	180 day outcomes	231 Participants
General Anesthesia	Need for Assistive Devices for Walking	365 day outcomes	193 Participants

Secondary

Overall Health and Disability

Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability.

Time frame: Approximately 60, 180, and 365 days after randomization

Population: Patients providing data at each time point

Arm	Measure	Group	Value (MEDIAN)
Regional Anesthesia	Overall Health and Disability	60-day outcome	22.7 score on a scale
Regional Anesthesia	Overall Health and Disability	180-day outcome	10.4 score on a scale
Regional Anesthesia	Overall Health and Disability	365-day outcome	10.4 score on a scale
General Anesthesia	Overall Health and Disability	180-day outcome	10.4 score on a scale
General Anesthesia	Overall Health and Disability	60-day outcome	18.2 score on a scale
General Anesthesia	Overall Health and Disability	365-day outcome	8.3 score on a scale

Secondary

Postoperative Delirium

Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium.

Time frame: Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first

Population: This outcome was assessed only among patients who had a negative 3D-CAM assessment for delirium before randomization.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Postoperative Delirium	130 Participants
General Anesthesia	Postoperative Delirium	124 Participants

Secondary

Satisfaction With Care

Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of dissatisfied or very dissatisfied to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general.

Time frame: Postoperative day 3 or day of discharge, whichever occurs first

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Regional Anesthesia	Satisfaction With Care	85 Participants
General Anesthesia	Satisfaction With Care	97 Participants

Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

Ability to Return to Home

Acute Postoperative Pain

All-cause Mortality

Chronic Pain

Cognitive Function

Inpatient Mortality

Major Inpatient Morbidity

Need for Assistive Devices for Walking

Overall Health and Disability

Postoperative Delirium

Satisfaction With Care