Multimodal Perioperative Pain Management: ComfortSafe Program

Status Recruiting

Clinical Trial Summary

Proposed is a demonstration project to characterize the immediate, short-term and long-term pain and other post-operative outcomes of 60, self-selected breast (n=20), caesarian-section (n=20) and abdominal (n=20) surgical patients who receive opioid-sparing, multimodal anesthesia and pain management care as guided by the ComfortSafe Pyramid.

Clinical Trial Description

In well-characterized samples of patients undergoing breast, caesarian-section or abdominal surgery, the efficacy and safety of perioperative pain care organized by ComfortSafe Pyramid approaches will be evaluated. In addition, patient satisfaction with this care will be evaluated. Post-operative pain and opioid-related outcomes will be operationalized using standardized symptom (nausea, vomiting, respiratory depression, confusion, acute and chronic pain) severity measures, prn analgesic (opioid and non-opioid) consumption, and urine toxicology. Together, these original data will have important implications for the clinical management of post-operative pain utilizing opioid-sparing and multi-modal approaches.

A total of 60 self-selected surgical patients will be enrolled in the study, 20 undergoing breast surgery, 20 undergoing caesarian-section, and 20 undergoing abdominal surgery. All will receive anesthesia and pain management consistent with the ComfortSafe Pyramid which emphasizes opioid-sparing and multimodal approaches. Side and adverse opioid-related effects and post-operative pain will be assessed at regular intervals during the immediate post-operative period (24 hours). To evaluate the incidence of opioid misuse/abuse and the development of chronic pain, an opioid use history, urine toxicology and Brief Pain Inventory will be collected at 1 month, 3 months and 6 months following discharge. Patient satisfaction measures will be obtained at discharge, 1 month, and 3 months follow-up timepoint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04046068
Study type	Observational
Source	Georgetown University
Contact	Lauren Payne, RN
Phone	2024445201
Email	lp827@georgetown.edu
Status	Recruiting
Phase
Start date	May 11, 2020
Completion date	September 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.