Status:

RECRUITING

Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy

Lead Sponsor:

University of Tennessee Graduate School of Medicine

Conditions:

Perioperative Opioid Sparing Techniques

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The primary purpose of this study is to determine if intrathecal morphine (ITM) administration is superior to quadratus lumborum block or surgeon administered transversus abdominis plane (TAP) blocks ...

Detailed Description

Enhanced recovery after surgery (ERAS) has become the standard of perioperative care for patients undergoing oncologic surgery. Multimodal and regional anesthetic techniques to reduce postoperative pa...

Eligibility Criteria

Inclusion

  • 18-80 years of age
  • Patients undergoing open surgery for foregut, HPB, and colorectal cancer
  • Able to read and understand study procedures
  • Willing to participate and sign an ICF
  • If female of childbearing potential, subject must have a negative pregnancy test
  • Recommended for adjuvant chemotherapy
  • Patients scheduled for an AM admit procedure
  • English speaking
  • Patients with a midline incision

Exclusion

  • Chronic Opioid Use (received an opioid within 90 days preoperatively)
  • Recreational Drug Use
  • Patients with cognitive impairments that can affect their ability to give consent
  • Patients that are currently taking anti-coagulants \<7 days prior to surgery
  • Pregnant or breastfeeding
  • Does not require adjuvant chemotherapy
  • Relative Contradictions for receiving a nerve block\*
  • Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy
  • Inability to provide consent
  • Absolute Contraindications
  • Lack of patient consent.
  • Skin infection at the site of needle insertion. Relative Contraindications
  • Coagulopathy
  • Systemic infection
  • Anatomical distortion
  • Neuropathy
  • Drugs/Device usage within 7 Days of Randomization if any:
  • • Anticoagulants

Key Trial Info

Start Date :

February 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 3 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT07153614

Start Date

February 3 2025

End Date

February 3 2027

Last Update

September 4 2025

Active Locations (1)

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1

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States, 37920