Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682367
Recruitment Status : Terminated (Poor Recruitment)
First Posted : September 24, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Narcotic Use Drug: Gabapentin Drug: Placebo - Concentrate Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All staff involved including nursing, surgeons, pain management, participants and PI will be blinded. Unmasked personnel only include research pharmacy staff.
Primary Purpose: Supportive Care
Official Title: Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Standard of care use of perioperative analgesia with acetaminophen and opioids that is supplemented with placebo solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and placebo.
Drug: Placebo - Concentrate
Use of sugar-free Placebo peri- and post-operatively.

Experimental: Intervention
Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.
Drug: Gabapentin
Use of Gabapentin peri- and post-operatively.
Other Names:
  • Neurontin
  • Gralise
  • Horizant




Primary Outcome Measures :
  1. Average Morphine Equivalent Units [ Time Frame: Perioperative. ]
    Determine the difference in average morphine equivalent units between experimental and control group.

  2. Average Morphine Equivalent Units [ Time Frame: 1 week post-operation. ]
    Determine the difference in average morphine equivalent units between experimental and control group.

  3. Average Morphine Equivalent Units [ Time Frame: 30 days post-operation. ]
    Determine the difference in average morphine equivalent units between experimental and control group.


Secondary Outcome Measures :
  1. Pain Score (10 point VAS) [ Time Frame: Perioperative, 1 week post-operation, 1 week post-discharge, and 30 days post-operation. ]
    Determine average change of inpatient Pain Score Visual Analog Scale (VAS) on a standardized 1 (no pain) to 10 (highest level of pain) scale between experimental and control groups.

  2. Post-operative Complications [ Time Frame: 30 days post-operation. ]
    Incidence of postoperative complications between experimental and control group.

  3. Narcotics-related Complications [ Time Frame: 30 days post-operation. ]
    Incidence of narcotics-related complications between experimental and control group.

  4. Inpatient Length of Stay [ Time Frame: 1 week post-operation. ]
    Determine the difference of average inpatient length of stay between experimental and control group.

  5. Inpatient Cost [ Time Frame: 1 week post-operation. ]
    Determine the difference of average inpatient cost between experimental and control group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing major head and neck surgery with concomitant free flap reconstruction surgery at UCDMC (oncology and non-oncologic): There will be two groups. Group 1 will include reconstruction with fibula free flap only. Group 2 will include any other free flap reconstruction, including scapular free flap, radial forearm free flap, anterolateral thigh free flap, anteromedial thigh free flap, and latissimus dorsi free flap.
  • Patients naïve to gabapentin
  • Adult patients >18 years of age and able to consent

Exclusion Criteria:

  • Patients who are already taking scheduled gabapentin
  • Patients allergic to gabapentin
  • Chronic opioid use not from active head and neck cancer
  • Illicit drug use (per report)
  • Patients with known renal compromise, such that Creatinine clearance is < 30
  • Patient with known hepatic insufficiency or cirrhosis
  • Adults unable to consent
  • Individuals less than 18 years old
  • Pregnant women
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682367


Locations
Layout table for location information
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Layout table for investigator information
Principal Investigator: Arnaud Bewley, MD University of California, Davis
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03682367    
Other Study ID Numbers: 1166778
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Davis:
Gabapentin
Narcotic
Cancer
Placebo
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents