Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04046068

Multimodal Perioperative Pain Management: ComfortSafe Program

Post-operative Pain Clinical Trial

Official title:
Improving Patient Outcomes Using Multimodal Perioperative Pain Management: The ComfortSafe Program

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
  Status Clinical Trial Phase
Completed NCT02489526 - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery Phase 2
Terminated NCT05146453 - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology Phase 4
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT03591172 - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization N/A
Completed NCT01667445 - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty Phase 4
Completed NCT01686802 - Post-operative Oral Morphine Versus Ibuprofen Phase 2
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Completed NCT00968955 - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty Phase 4
Completed NCT00830089 - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery N/A
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT00847093 - LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery Phase 4
Completed NCT00390312 - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Phase 2
Recruiting NCT05278494 - Dextromethorphan for Treatment of Postoperative Pain N/A
Recruiting NCT05973045 - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy N/A
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A
Enrolling by invitation NCT04346407 - Dronabinol for Post-operative Pain After Lumbar Fusion Phase 4
Completed NCT03635515 - Occurrence of Post-op Pain Following Gentlewave N/A
Terminated NCT03201809 - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial N/A
Completed NCT03254056 - Fascial Closure Techniques Post-Operative Pain Laparoscopy N/A