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

• Sponsor: Methodist Health System (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06095453
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Outcome Measures

Primary Outcome Measures

1. Narcotics Doses and timeframe [4 months]

   number of doses of narcotics taken including the number of times refilled.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

• Principal Investigator: Joshua Trussell, MD, Mansfield

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT06095453
• Other Study ID Numbers: 124.SUR.2022.M
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain; Narcotics

Study Results

No Results Posted as of Oct 23, 2023