Clinical trial NCT05997355: Preoperative Gabapentin for Cosmetic Breast Surgery
Official title: "Preoperative Gabapentin and Its Effects on Postoperative Analgesia in Patients Undergoing Cosmetic Breast Surgery"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Treatment with gabapentin vs no treatment
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare postoperative pain and opioid consumption in patients who undergo cosmetic breast surgery and are treated preoperatively with gabapentin. The main questions to answer are the amount of postoperative pain on a scale of 0-10 and amount of opioids consumed postoperatively. Participants will be randomized into two groups: treatment vs no treatment. Treatment group will receive 600mg of gabapentin preopreatively. Researchers will compare treatment vs no treatment group to determine the effects of preoperative gabapentin on postoperative pain management and opioid consumption.

Detailed description: HYPOTHESIS We hypothesize that a single dose of preoperative gabapentin will improve postoperative pain scores and decrease postoperative opioid requirements in our study population. This will be tested by administering a preoperative dose of 600mg of gabapentin and measuring pain scores and amount of opioid consumption during the postoperative period. The study will compare two groups. Participants will be randomly assigned to one of the two groups and will consist of a treatment group and a control group. We will measure pain scores in a simple 0-10 scale and amount of opioid consumption during the first 7 days after discharge and compare them with patients who did not receive preoperative gabapentin. Our aims are to determine if gabapentin improves postoperative analgesia and reduces postoperative opioid requirements in a population undergoing cosmetic breast surgery

METHODOLOGY AND STUDY DESIGN

This study will be a randomized control trial. Participants will be randomized and divided into treatment versus no treatment group. Treatment group will be administered a dose of 600mg of gabapentin within 2 hours of surgery. Amount of postoperative opioids will be measured for 7 days, post op pain scores will be measured twice daily for 7 days. This information will be collected via postoperative questionnaires.

STUDY SUBJECTS Participants will be adult, non pregnant patients older than 18 years undergoing cosmetic breast surgery at either Hospital Oncologico Isaac Gonzalez Martinez or Hospital UPR Federico Trilla. Participants will be selected during the initial clinic visit, there will be no specific recruiting strategies. Excluded populations include minors 18 years old or less as well as pregnant females due to health concerns. Participants will be explained in detail the goal and objectives of study along with risks vs benefits. The following HIPAA identifiers will be excluded: Geographical elements, fax numbers, social security numbers, health insurance beneficiary numbers, vehicle identifiers, digital identifiers, digital attributes, IP addresses, biometric elements and full face photographic images.

VARIABLES

Primary outcomes will be the amount of postoperative pain and amount of postoperative opioid consumption. Postoperative pain will be defined and measured as a score from 1-10. Opioid consumption will be defined and measured as the amount of standard doses used in the postoperative period. Prior chronic gabapentin or opioid use will also be a variable accounted for to eliminate confounding effects of tachyphylaxis.

ANALYTIC PLAN Data will be organized in tables and analyzed with simple t-test to compare mean pain scores and amount of postoperative opioid consumption. Data will be stored within a shared google drive folder in a private excel/google sheets document. Each researcher listed in the study protocol will have access to the data individually via their own electronic devices in order to access when needed. CO-PI will administer privacy settings and provide access to each researcher. Data checks will periodically be performed to ensure data consistency.

Eligibility criteria: Inclusion Criteria:

* adults 18 to 65 y/o without chronic gabapentin and/or opioid use

Exclusion Criteria:

* minors less than 18 y/o, adults older than 65 y/o, chronic users of gabapentin and/or opioids, pregnant females

Primary outcomes:
measure: Postoperative pain
timeFrame: Days 1-7 postoperatively
measure: Postoperative opioid consumption
timeFrame: Days 1-7 postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: angel.rivera56@upr.edu
name: Angel Rivera Barrios, MD
role: PRINCIPAL_INVESTIGATOR
References:
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