Sarcoma
Conditions
Keywords
Enhanced Recovery After Surgery
Brief summary
The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.
Detailed description
Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores \[PROMIS\] and \[QoR-15\]), limb function scores \[MSTS\], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).
Interventions
PROCEDUREEnhanced Recovery After Surgery
Undergo an enhanced recovery after surgery program
Sponsors
Joshua Lawrenz
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma * Adult patients \>17 years of age * Patients of all preoperative opioid status (naïve or dependent)
Exclusion criteria
* Patients treated non-operatively * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 3 months | Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time) |
| Limb function | 3 months | Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst) |
| Clinical outcomes - length of hospital stay | 3 months | Measured by the number of days in the hospital |
| Clinical outcomes - opioid requirements | 3 months | Measured by the amount of opioids consumed |
| Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission) | 3 months | Measured by the number of perioperative complications reported |
Countries
United States
Contacts
CONTACTVanderbilt-Ingram Service for Timely Access
PRINCIPAL_INVESTIGATORJoshua Lawrenz, MD
Vanderbilt Medical Center
Outcome results
None listed