Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs

Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. I

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Other: Pain control regimens

Detailed Description

This performance improvement study is a retrospective review of data obtained from patients at Methodist Mansfield Medical Center (MMMC) in Mansfield, Texas from May 1, 2022 to September 30, 2022. Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

Description

Inclusion Criteria:

Patients of the five physicians of the SAM group Patients ≥18 years Patients undergoing urgent or elective laparoscopic and robotic cholecystectomy OR patients undergoing urgent or elective laparoscopic, robotic or open hernia repair (ventral, umbilical, or inguinal).

Exclusion Criteria:

Patients <18 years Patients with chronic pain conditions managed with chronic use of narcotics Patients that underwent incisional hernia repairs Patients that underwent complicated hernia repairs that included other operations such as colon and bowel resection procedures

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotics Doses and timeframe	number of doses of narcotics taken including the number of times refilled.	4 months

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Joshua Trussell, MD, Mansfield

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics
• Other Study ID Numbers: 124.SUR.2022.M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 8.5. Data Use and Sharing Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Medical Electronic devices
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No