Postop Pain in the MICS Patients Versus Sternotomy Patients

Surgery Clinical Trial

Official title:

Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003584
• Other study ID #: IRB file #09-17-29E
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: June 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville

• Minimally invasive cardiac surgery

• Traditional sternotomy cardiac surgery

Exclusion Criteria:

• Documented history of any chronic pain syndromes requiring active treatment

• The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation

• Any CABG operation that inadvertently resulted in an operative surgical complication

• Patient cases that resulted in a readmission within 30 days from surgery.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery

Intervention

Procedure:
• Coronary bypass surgery
Reviewed postoperative coronary bypass patients and compared postoperative pain levels

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest reported pain level, on the standard 0-10 pain scale, post extubation day one	The highest recorded pain level, taken by the nursing staff, on the day following. extubation. Utilized day post due to the washout/possible confounding variable of sedation administration within 24hrs.	The first 24 hours post extubation
Primary	Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge.	The highest reported pain, measured by the nursing staff on within 24hrs from discharge.	Within 24 hours from discharge