Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03682367 |
| Other study ID # |
1166778 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2018 |
| Est. completion date |
April 6, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Patients undergoing head and neck cancer surgery frequently experience significant post
surgical pain, which often necessitates the use of narcotic pain medication. However, opioids
can have multiple side effects that can complicate the head and neck cancer surgery patients
postoperative care including nausea, vomiting, dizziness, sedation, pruritis, urinary
retention, delirium, constipation, and time to ambulation. This, in turn, may affect patient
length and cost of hospital stay. Consequently, a multimodal approach to analgesia is often
employed with a focus on use of scheduled acetaminophen +/- NSAIDs supplemented with
narcotics.
The use of gabapentin in the head and neck surgery literature has largely been limited to
outpatient surgeries, including tonsillectomy in children and adults, functional endoscopic
sinus surgery, and thyroidectomy. Indeed, a recent systematic review examined RCT comparing
multimodal analgesia with gabapentin to analgesia without gabapentin in the otolaryngology
literature. The majority of these studies employed preoperative dosing only, with only 1
study providing a single postoperative dose as well. The control group pain regimen among
these studies did vary and included a combination of acetaminophen, NSAIDs, dexmedetomidine,
or clonidine supplemented with opioids. The studies focused on the impact of gabapentin on
acute postoperative pain determined by subjective measurement of reduction in visual analog
pain scale. Of note, these patients were not hospitalized for longer than 24 hours. The
thyroid and sinus studies consistently demonstrated improved pain control with use of
gabapentin compared to control. The data was slightly more variable across the tonsillectomy
studies. Moreover, 7 studies also measured the need for breakthrough pain medication and
supplemental analgesia; each of these studies demonstrated significantly less supplemental
analgesia consumption in the gabapentin group.
The only study examining the utility of gabapentin in pain management in head and neck cancer
patients (glossectomy with anterolateral thigh free flap) examined the utility of a single
preoperative dose. The authors concluded that this led to a significant reduction in
subjective postoperative pain scores, morphine requirement, and nausea and vomiting compared
to controls. This study did not employ postoperative gabapentin.
Furthermore, a recent meta analysis (133 RCT) examining literature across multiple surgical
specialties pertaining to the efficacy of perioperative gabapentin supplementation vs
placebo. The meta analysis indicated both the efficacy of gabapentin supplementation in
decreasing opioid requirement (measured via morphine equivalent units) in the experimental
group during the first 24 hours (P<0.001), as well as a good safety profile across a wide
range of loading and maintenance doses (200 to 1200 mg) of gabapentin. The significant
reduction in opioid requirement was independent of surgery type. Moreover, the gabapentin
group demonstrated a significant decrease in VAS postoperative pain scores, nausea, vomiting
and itching; however, sedation scores were increased. Only 8 of these 133 RCT examined the
effect of gabapentin outside the immediate 24 hour period, and all 8 trials demonstrated
improvement in chronic pain scores at 3 months post-operatively. Finally, patient
satisfaction scores and preoperative anxiety were also significantly improved with the use of
gabapentin compared to controls.
Here, the investigators propose, for the first time, a superiority double blind randomized
controlled placebo trial examining the effect of perioperative supplementation with
gabapentin in head and neck cancer patients undergoing surgery. The primary purpose of this
study is to determine the difference in morphine equivalent units between the experimental
(i.e. perioperative gabapentin) and control group (i.e. no perioperative gabapentin). The
secondary purpose of this study is to determine differences across the two groups in relation
to the following: visual analog pain scores, cost and length of stay, medication side
effects, and incidence of postoperative complications. Of note, in order to maximize
reliability of the visual analog scale (VAS), prior studies have employed the Jadad scoring
system, which the investigators will also implement in the study.
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