Enhanced Recovery After Bilateral Reduction Mammaplasty

Pain Clinical Trial

Official title:

Enhanced Recovery After Bilateral Reduction Mammaplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04558840
• Other study ID #: STU 2020-0813
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.

Description:

This is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. This study is designed to follow one-hundred (100) qualified and consenting patients seeing the PI/surgeon (JMK) at his office at UT Southwestern for their initial operative consultation for macromastia. If patients meet eligibility criteria, they will be offered enrollment in the trial.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: November 30, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting

• Age 18 and older

• BMI less than 40, non-smokers.

Exclusion Criteria:

• age less than 18,

• BMI over 40,

• smokers,

• uncontrolled diabetes,

• American Society of Anesthesiologists (ASA) status scores 3 or higher

• patients with allergies to any of the medications in the ERAS or current practice regiments (gabapentin, celecoxib, ketorolac, ondansetron, or hydrocodone).

• History of narcotic or IV drug abuse

• History of chronic pain

• Hypersensitivity or allergy to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen or acetaminophen

• Current pregnancy or planning pregnancy in the next xx weeks/ months

• Contraindications to NSAID drugs (ketorolac, ibuprofen, celecoxib): coagulation disorder, active bleeding, severe renal impairment, hepatic impairment.

• Contraindications to gabapentin: caution for CrCl <60, caution in elderly, caution if alcohol consumption

• Contraindications to acetaminophen: hepatic or renal impairment, chronic alcohol use

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Macromastia
Patients with macromastia seeing the principle investigator (PI) (JMK) at his office at the Outpatient Building, which includes the Outpatient Surgery Center (OSC), in the Department of Plastic Surgery clinic at UT-Southwestern for their initial operative consultation for reduction mammaplasty will be offered enrollment in the trial if they are deemed appropriate surgical candidates, based on the PI's clinical judgement and expertise.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Pain Questionnaire	Determine the efficacy of non-narcotic pain regiments in patients undergoing breast reduction surgery and compare it to narcotic-based pain regiments in improving post-operative pain in patients undergoing breast reduction surgery.; Patients will be asked to rate their pain from a scale of 0 ("No Pain") to 10 ("Pain as bad as you can imagine").	Day 0 - Day 7
Secondary	Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome	The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST-Q Postoperative Reduction Module Satisfaction with Outcome.; Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.	Day 0- Day 7
Secondary	Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey	The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST- Q Postoperative Reconstruction Module Satisfaction with Information Survey.; Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.	Day 0- Day 7
Secondary	Post operative Quality of Life Questionnaire	The following questionnaires will be used to track the patients satisfaction following their procedure.; The postoperative questions do not have an applicable scale.	Day 0- Day 7