Opioid Free Anesthesia vs. Opioid Anesthesia Techniques. (OFA vs OA)

University of South Florida

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colectomy; Analgesic Drug Dependence

Treatments: Drug: Opioid Anesthesia; Drug: Opioid-free Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03367988

Pro00032413

Details and patient eligibility

About

A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.

Full description

The study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at Tampa General Hospital. After consent is obtained patients will be electronically randomized using REDCap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. Patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. This will be done through a data mining platform and service known as REDCap. REDCap is partnered with USF to allow for subject management, data collection and the distribution of surveys via mobile phone. All data collected by REDCap is stored on a HIPPA compliant server. Patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. Confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, Dr. Camporesi. In addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the PACU

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care
• Adults aged 18 and older

Exclusion criteria

• Patients who are pregnant
• Patients that are not registered within Tampa General Hospital Electronic Medical Records System
• Patients without smart phone capabilities
• Patients younger than 18 years
• Patients older than 80 years
• Patients who cannot speak or read English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Opioid-free Anesthesia

Experimental group

Description:

Patients will receive no intraoperative narcotics as part of their anesthesia regimen

Treatment:

Drug: Opioid-free Anesthesia

Opioid Anesthesia

Active Comparator group

Description:

Patients will receive intraoperative narcotics as part of their anesthesia regimen

Treatment:

Drug: Opioid Anesthesia