Enhanced Recovery After Surgery in Extremity Sarcoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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Enhanced Recovery After Surgery in Extremity Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Procedure: Enhanced Recovery After Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS<br>Administration of a perioperative non-narcotic, multimodal pain management pathway. | Procedure: Enhanced Recovery After Surgery<br>* Undergo an enhanced recovery after surgery program<br>|
| No Intervention: Non-ERAS (Conventional)<br>Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time) | 3 months | 
| Pain scores | Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best) | 3 months | 
| Limb function | Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst) | 3 months | 
| Clinical outcomes - length of hospital stay | Measured by the number of days in the hospital | 3 months | 
| Clinical outcomes - opioid requirements | Measured by the amount of opioids consumed | 3 months | 
| Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission) | Measured by the number of perioperative complications reported | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced Recovery After Surgery