Hip-fracture, Surgery
Conditions
Keywords
elderly, acetaminophen, oral vs intravenous, hip fracture surgery
Brief summary
The INTACT-HIP trial study will evaluate feasibility of conducting a randomized, double-blinded controlled trial comparing postoperative treatment with intravenous (IV) acetaminophen versus oral acetaminophen, in older adults undergoing hip fracture surgery. The results of this feasibility trial will be used to inform designing a larger, multi-center, randomized controlled trial to assess the efficacy of IV acetaminophen compared to oral acetaminophen to reduce delirium and improve other clinical and patient-centered outcomes after hip fracture surgery. It will randomize 42 older adults to receive either oral or IV acetaminophen after hip fracture surgery.
Interventions
DRUGIntravenous (IV) acetaminophen + oral placebo
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
DRUGIntravenous (IV) placebo plus oral acetaminophen
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group the IV study drug will be normal saline and the pill will be acetaminophen
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple blinded
Intervention model description
The study intervention will start after the surgery for the hip fracture with administration of the study drugs, starting in the post-anesthesia care unit (PACU). All patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In the intravenous (IV) group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet; vice versa, in the per oral (PO) group, the IV study drug will be normal saline and the pill will be acetaminophen. After 48 hours, all the patients will receive oral acetaminophen every 6 hours as per usual practice
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years of age and older * Patients who were ambulating without human assistance before fracture, with any type of non-neoplastic hip fracture * Patients undergoing surgical treatment as an inpatient
Exclusion criteria
* Patients with neoplastic hip fracture * Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) \<10) * Pre-existing delirium * Known hypersensitivity or allergy to acetaminophen * Severe or chronic liver or kidney dysfunction * Planned postoperative ventilation * Swallowing issues and/or dysphagia * English language limitation * Weight \<50kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial feasibility-Recruitment | 30 days | Feasibility as assessed by recruitment rate. This will be assesses as proportion of patients enrolled in the study compared to the number of patients meeting the inclusion/exclusion criteria. |
| Trial feasibility-Attrition | 30 days | Feasibility as assessed by attrition rates. This will be defined as the proportion of patients completing the study at follow-up compared to the enrolled patients. |
| Trial feasibility-Availability of human resources | 30 days | Feasibility as assessed by lack of availability of human resources). Inability to include patient in study due to lack of pharmacist or research assistant availability will be documented. |
| Trial feasibility-Comply study procedures | 30 days | Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented. |
| Trial safety | 30 days | Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Before surgery, on day of surgery, and days 1,2,3 after surgery | Pain will be assessed using the visual analogue (VAS) scale (0-10) at rest and movement, with 0=no pain and 10=worst pain possible |
| Opioid consumption | Before surgery, on day of surgery, and days 1,2,3 after surgery | Oral morphine equivalents (OMEQS) in milligrams |
| Delirium | On day of surgery, and days 1,2, 3 after surgery | Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form |
| Cognitive dysfunction | Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery) | Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA) |
| Overall health and disability | Baseline and at 30 days after surgery | Overall health and disability will be measured using the WHO Disability Assessment Schedule, version 2.0 (WHODAS 2.0), a 12-item validated measure that assesses cognition, mobility, self-care, interpersonal relationships, work and household roles, and participation in society |
| Depression screen | Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery) | Patient Health Questionnaire (PHQ)-2 a 2-question questionnaire will be used as a validated measure to screen for depression. |
| Ambulation | Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery) | Ambulation will be assessed as the ability to walk 10 feet or across a room without human assistance |
| Post-operative adverse events | On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery | Post-operative adverse events will be obtained from the study institution's National Surgical Quality Improvement Project (NSQIP) database as as death, ICU admission, standardized cardiac, respiratory and neurological postoperative events, and readmission to hospital. |
| Discharge location | At the time of discharge (at 1-3 days after surgery in most cases) | Location of discharge after surgery |
Countries
Canada
Contacts
CONTACTLaurentia Enesi
CONTACTAparna P Saripella
PRINCIPAL_INVESTIGATORJean Wong, MD
University Health Network, Toronto
Outcome results
None listed