Preoperative Gabapentin for Cosmetic Breast Surgery

NCT05997355 | Unknown DMC

• 1 other identifier: B3650222
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Amount of postoperative pain on a scale from 1-10

  Days 1-7 postoperatively

• Postoperative opioid consumption

  Amount of postoperative standardized opioid doses

  Days 1-7 postoperatively

Study Arms (2)

Treatment

EXPERIMENTAL

Patient will be treated with preoperative gabapentin

Drug: Gabapentin 600Mg Tab

No treatment

NO INTERVENTION

Patient will not be treated with preoperative gabapentin

Interventions

Gabapentin 600Mg Tab DRUG

A single preoperative dose of gabapentin 600mg

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Puerto Rico: lead

Related Publications (9)

• Chang CY, Challa CK, Shah J, Eloy JD. Gabapentin in acute postoperative pain management. Biomed Res Int. 2014;2014:631756. doi: 10.1155/2014/631756. Epub 2014 Apr 14.

  PMID: 24829909 BACKGROUND

• Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.

  PMID: 16636030 BACKGROUND

• Liu B, Liu R, Wang L. A meta-analysis of the preoperative use of gabapentinoids for the treatment of acute postoperative pain following spinal surgery. Medicine (Baltimore). 2017 Sep;96(37):e8031. doi: 10.1097/MD.0000000000008031.

  PMID: 28906391 BACKGROUND

• Mao Y, Wu L, Ding W. The efficacy of preoperative administration of gabapentin/pregabalin in improving pain after total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Aug 30;17(1):373. doi: 10.1186/s12891-016-1231-4.

  PMID: 27577678 BACKGROUND

• Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.

  PMID: 30519075 BACKGROUND

• Rai AS, Khan JS, Dhaliwal J, Busse JW, Choi S, Devereaux PJ, Clarke H. Preoperative pregabalin or gabapentin for acute and chronic postoperative pain among patients undergoing breast cancer surgery: A systematic review and meta-analysis of randomized controlled trials. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1317-1328. doi: 10.1016/j.bjps.2017.05.054. Epub 2017 Jun 9.

  PMID: 28751024 BACKGROUND

• Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.

  PMID: 12218520 BACKGROUND

• Freedman BM, O'Hara E. Pregabalin has opioid-sparing effects following augmentation mammaplasty. Aesthet Surg J. 2008 Jul-Aug;28(4):421-4. doi: 10.1016/j.asj.2008.04.004.

  PMID: 19083556 BACKGROUND

• 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.

  PMID: 29979365 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Angel Rivera Barrios, MD

  angel.rivera56@upr.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel A Serpa Irizarry, MD

CONTACT

7876430397; miguel.serpa@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Treatment with gabapentin vs no treatment

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: September 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During the complete duration of the study
• Access Criteria: Researchers will be invited by PI or CO-PI to shared folder. Information will not be shared outside of research group nor made public