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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957097
Recruitment Status : Not yet recruiting
First Posted : November 6, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffry R. Shaefer, MD, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to assess the effectiveness of pre-operative administration of gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and maxillofacial surgical procedures.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Acute Pain Facial Pain Drug: Gabapentin Drug: Placebo Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medication - Gabapentin
Participants of this group will be administered either Gabapentin 900 milligram PO 2-3 hours prior to the surgical procedure.
Drug: Gabapentin
Medication used for management of neuropathic pain conditions
Other Names:
  • Neurontin
  • Gralise
  • Horizant

Placebo Comparator: Medication - Placebo
Participants of this group will be administered either Placebo PO 2-3 hours prior to the surgical procedure.
Drug: Placebo
Placebo medication. It looks exactly same as the Gabapentin medication in same size, shape, and color.




Primary Outcome Measures :
  1. Intensity of pain [ Time Frame: 6 hours postoperatively ]
    Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  2. total opioid consumption [ Time Frame: 24 hours ]
    Consumption of opioid medication postoperatively

  3. time to first rescue analgesic [ Time Frame: post-operatively (up to 6 hours) ]
  4. incidence of adverse effects [ Time Frame: post-operatively (up to 24 hours) ]
  5. Intensity of pain [ Time Frame: 12 hours postoperatively ]
    Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  6. Intensity of pain [ Time Frame: 24 hours postoperatively ]
    Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  7. Intensity of pain [ Time Frame: 72 hours postoperatively. ]
    Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  8. total opioid consumption [ Time Frame: 72 hours post-operatively ]
    Consumption of opioid medication postoperatively.


Secondary Outcome Measures :
  1. incidence of pain [ Time Frame: 1 month ]
    incidence of pain after 1 month postoperatively

  2. intensity of pain on a numeric rating scale (0-10) [ Time Frame: 1 month ]
    intensity of pain after 1 month post-operative. Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  3. length of post-operative hospital-stay [ Time Frame: postoperatively in terms of days (up to 1 week) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participants, of any race, between ages of 18 - 65 years.
  2. Participants undergoing unilateral or bilateral Lefort osteotomy, unilateral or bilateral mandibular inverted-L or sagittal split osteotomy with or without genioplasty, temporomandibular joint arthroplasty with or without total joint replacement prosthesis.

Exclusion Criteria:

  1. Participants who are pregnant.
  2. Participants allergic to gabapentin.
  3. Participants with a history of alcohol, or drug abuse.
  4. Participants who are unwilling to participate, or are non-compliant to the guidelines of the investigation.

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): NCT02957097


Contacts
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Contact: Steven J Scrivani, DDS, DMedSc 617-726-8222 Sscrivani1@partners.org
Contact: Khawaja S Nasir, BDS, MS 435-710-1080 ksnasir@partners.org

Locations
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United States, Massachusetts
Department of Oral and Maxillofacial Surgery, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Publications:

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Responsible Party: Jeffry R. Shaefer, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02957097    
Other Study ID Numbers: ksn17
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffry R. Shaefer, MD, Massachusetts General Hospital:
Gabapentin
acute pain
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Facial Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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