Trial · NCT02507505
Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
NCT02507505, Not applicable, Completed, University of Pennsylvania; results first posted 2024-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regional Versus General Anesthesia for Promoting Independence After Hip Fracture. Trials, record NCT02507505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02507505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
- NCT number
- NCT02507505
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,848 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Hip Fractures
- Interventions
- Regional Anesthesia, General Anesthesia
- First posted
- 2015-07-24
- Last updated
- 2024-05-13
- Results first posted
- 2024-05-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | All-cause Mortality | Approximately 60, 180, and 365 days after randomization | Will be assessed via telephone interview and National Death Index (NDI) search |
| Secondary | Need for Assistive Devices for Walking | Approximately 60, 180, and 365 days after randomization | Will be assessed via telephone interview |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Approximately 60 days after Randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Health and Disability | Approximately 60, 180, and 365 days after randomization | Patients providing data at each time point | score on a scale | MEDIAN |
| SECONDARY | Ability to Return to Home | Approximately 60, 180, and 365 days after randomization | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Chronic Pain | Approximately 60, 180, and 365 days after randomization | Numbers differ across rows due to missing data | units on a scale | MEAN |
| SECONDARY | Cognitive Function | Baseline and approximately 60, 180, and 365 days after randomization | Numbers differ across rows due to missing data | units on a scale | MEDIAN |
| SECONDARY | All-cause Mortality | Approximately 60, 180, and 365 days after randomization | All enrolled patients who had not withdrawn or been lost to follow up a given study time point | participants | NUMBER |
| SECONDARY | Need for Assistive Devices for Walking | Approximately 60, 180, and 365 days after randomization | 60-day outcome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acute Postoperative Pain | Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first | units on a scale | MEAN | |
| SECONDARY | Satisfaction With Care | Postoperative day 3 or day of discharge, whichever occurs first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postoperative Delirium | Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first | This outcome was assessed only among patients who had a negative 3D-CAM assessment for delirium before randomization. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Regional Anesthesia | 132 | Participants | ||
| Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | General Anesthesia | 132 | Participants | ||
| Overall Health and Disability | Regional Anesthesia | 60-day outcome | 22.7 | Inter-Quartile Range 8.3 to 43.2 | score on a scale |
| Overall Health and Disability | General Anesthesia | 60-day outcome | 18.2 | Inter-Quartile Range 6.3 to 31.8 | score on a scale |
| Overall Health and Disability | Regional Anesthesia | 180-day outcome | 10.4 | Inter-Quartile Range 2.3 to 27.1 | score on a scale |
| Overall Health and Disability | General Anesthesia | 180-day outcome | 10.4 | Inter-Quartile Range 2.1 to 27.3 | score on a scale |
| Overall Health and Disability | Regional Anesthesia | 365-day outcome | 10.4 | Inter-Quartile Range 2.1 to 29.2 | score on a scale |
| Overall Health and Disability | General Anesthesia | 365-day outcome | 8.3 | Inter-Quartile Range 0 to 22.9 | score on a scale |
| Ability to Return to Home | Regional Anesthesia | 60-day outcomes | 108 | Participants | |
| Ability to Return to Home | General Anesthesia | 60-day outcomes | 114 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regional Anesthesia | 795 | |
| Overall Study | STARTED | General Anesthesia | 805 | |
| Overall Study | COMPLETED | Regional Anesthesia | 712 | |
| Overall Study | COMPLETED | General Anesthesia | 733 | |
| Overall Study | NOT COMPLETED | Regional Anesthesia | 83 | |
| Overall Study | NOT COMPLETED | General Anesthesia | 72 |
Source ClinicalTrials.gov
Adverse events886
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Regional Anesthesia | 73 | 795 | |
| other | Anemia | Blood and lymphatic system disorders | General Anesthesia | 75 | 805 | |
| other | Anemia iron deficiency | Blood and lymphatic system disorders | Regional Anesthesia | 0 | 795 | |
| other | Anemia iron deficiency | Blood and lymphatic system disorders | General Anesthesia | 1 | 805 | |
| other | Hemolysis | Blood and lymphatic system disorders | Regional Anesthesia | 1 | 795 | |
| other | Hemolysis | Blood and lymphatic system disorders | General Anesthesia | 0 | 805 | |
| other | Hemolytic uremic syndrome | Blood and lymphatic system disorders | Regional Anesthesia | 0 | 795 | |
| other | Hemolytic uremic syndrome | Blood and lymphatic system disorders | General Anesthesia | 1 | 805 | |
| other | Hypoplastic marrow | Blood and lymphatic system disorders | Regional Anesthesia | 0 | 795 | |
| other | Hypoplastic marrow | Blood and lymphatic system disorders | General Anesthesia | 1 | 805 |
1 to 10 of 886Source ClinicalTrials.gov
See all 886 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regional Anesthesia | 98 | 795 |
| Total, all-cause mortality | General Anesthesia | 92 | 805 |
| Total, other adverse events | Regional Anesthesia | 278 | 795 |
| Total, other adverse events | General Anesthesia | 286 | 805 |
| Total, serious adverse events | Regional Anesthesia | 255 | 795 |
| Total, serious adverse events | General Anesthesia | 242 | 805 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regional Anesthesia vs General Anesthesia: Inpatient Mortality | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Satisfaction With Care | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Postoperative Delirium | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Major Inpatient Morbidity | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: deaths from any cause | Trial comparisons |
| Regional Anesthesia vs General Anesthesia: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02507505
GET https://conductscience.org/api/trials/v1/NCT02507505/results?page=2