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Enhanced Recovery After Surgery in Extremity Sarcoma

J

Joshua Lawrenz

Status

Enrolling

Conditions

Sarcoma

Treatments

Procedure: Enhanced Recovery After Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04461171
VICC SAR 2020

Details and patient eligibility

About

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.

Full 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).

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

120 participants in 2 patient groups

ERAS
Experimental group
Description:
Administration of a perioperative non-narcotic, multimodal pain management pathway.
Treatment:
Procedure: Enhanced Recovery After Surgery
Non-ERAS (Conventional)
No Intervention group
Description:
Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Vanderbilt-Ingram Service for Timely Access

Data sourced from clinicaltrials.gov

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