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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Pain after surgery is a significant acute clinical symptom. It is associated with quality of post-operative recovery, time spent in the hospital, post-discharge care and readmissions, morbidity, psychosocial distress, and cost of care. The management of acute postsurgical pain primarily consists of a multimodal approach consisting of opioids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics. The associated adverse effects often limit the use of such multimodal pharmacotherapy. Opioids have excellent analgesic properties, however are associated with poor adverse-effects profile. They have been associated with nausea, vomiting, somnolence, and urinary retention. Such adverse-effects may decrease the quality of post-operative recovery, increase patient post-surgical management, and overall cost of care. Moreover, in patients undergoing oral and maxillofacial surgical procedures, such adverse-effects may be further potentiated due to placement of reconstructive plates, screws, and maxillomandibular fixation. In order to improve post-surgical quality of care, researchers have been looking for alternative modalities for the management of acute post-surgical pain. One of such modalities has been use of preemptive analgesic therapy. Preemptive analgesia is defined as a treatment modality that is initiated before a traumatic event, such as, surgical incision or tissue manipulation is introduced. Gabapentin is an antiepileptic drug that has been used in the management of painful neuropathies, such as, diabetic poly-neuropathy, post-herpetic neuralgia, and trigeminal neuropathy. Gabapentin has antiallodynic and antihyperalgesic properties with only a minor effect on normal nociception. It reduces the hyperexcitability of dorsal horn neuron induced by tissue injury, as well as, central sensitization induced after trauma and surgery. Gabapentin has been studied extensively as a preemptive analgesic
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• 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.
• total opioid consumption [ Time Frame: 24 hours ]
  Consumption of opioid medication postoperatively
• time to first rescue analgesic [ Time Frame: post-operatively (up to 6 hours) ]
• incidence of adverse effects [ Time Frame: post-operatively (up to 24 hours) ]
• 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.
• 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.
• 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.
• total opioid consumption [ Time Frame: 72 hours post-operatively ]
  Consumption of opioid medication postoperatively.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• incidence of pain [ Time Frame: 1 month ]
  incidence of pain after 1 month postoperatively
• 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.
• length of post-operative hospital-stay [ Time Frame: postoperatively in terms of days (up to 1 week) ]

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: July 21, 2016
Date Started: April 2017
Date Completion: July 2018
Last Updated: March 23, 2017
Last Verified: March 2017