Preoperative Gabapentin for Cosmetic Breast Surgery

NCT ID: NCT05997355

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-07-31

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.

Conditions

Postoperative Pain; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patient will be treated with preoperative gabapentin

Group Type: EXPERIMENTAL

Gabapentin 600Mg Tab

Intervention Type: DRUG

A single preoperative dose of gabapentin 600mg

No treatment

Patient will not be treated with preoperative gabapentin

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gabapentin 600Mg Tab

A single preoperative dose of gabapentin 600mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Miguel Serpa Irizarry

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angel Rivera Barrios, MD

Role: PRINCIPAL_INVESTIGATOR

angel.rivera56@upr.edu

Central Contacts

Miguel A Serpa Irizarry, MD

Role: CONTACT

miguel.serpa@upr.edu

7876430397

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Barker JC, DiBartola K, Wee C, Andonian N, Abdel-Rasoul M, Lowery D, Janis JE. Preoperative Multimodal Analgesia Decreases Postanesthesia Care Unit Narcotic Use and Pain Scores in Outpatient Breast Surgery. Plast Reconstr Surg. 2018 Oct;142(4):443e-450e. doi: 10.1097/PRS.0000000000004804.

Reference Type: BACKGROUND

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Other Identifiers

B3650222

Identifier Type: -

Identifier Source: org_study_id