Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-24

Study Completion Date

2017-06-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures

NCT02957097

Pain, Postoperative Acute Pain Facial Pain

WITHDRAWN PHASE4

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

NCT03682367

Cancer of Head and Neck Narcotic Use

TERMINATED PHASE3

Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?

NCT00934193

Post-thoracotomy Pain

WITHDRAWN PHASE3

Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management

NCT02703259

Pain, Postoperative

COMPLETED PHASE4

Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting

NCT00886236

Obesity, Morbid Postoperative Pain Postoperative Nausea and Vomiting

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer Acute Pain Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gabapentin

Gabapentin liquid by mouth or Per Tube 300mg twice a day

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Placebo

Placebo liquid by mouth or Per Tube twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
* At least one night of planned inpatient stay

Exclusion Criteria

* Incapable of giving informed consent
* Age less than 18
* Glomerular Filtration Rate (GFR) less than 30
* Allergy to gabapentin
* Baseline gabapentin or lyrica use
* Chronic opioid use for over six months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No