Sacramento, California 95817


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients undergoing head and neck cancer ablation with concomitant free flap reconstruction surgery at UCDMC. 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


Study is Available At:


Original ID:

1166778


NCT ID:

NCT03682367


Secondary ID:


Study Acronym:


Brief Title:

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery


Official Title:

Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery: A Randomized Controlled Trial


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Arnaud Bewley, MD
Principal Investigator
University of California, Davis
Primary Contact:Angela Beliveau, MPH, CCRP
916-734-2704
ambeliveau@ucdavis.edu

Study Dates

Start Date:December 1, 2018
Completion Date:October 1, 2020
Completion Type:Anticipated
Primary Completion Date:August 1, 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 2, 2019
First Received Date:September 21, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Average Morphine Equivalent Units
Time Frame:Perioperative.
Safety Issues:False
Description:Determine the difference in average morphine equivalent units between experimental and control group.
Outcome Type:Primary Outcome
Measure:Average Morphine Equivalent Units
Time Frame:1 week post-operation.
Safety Issues:False
Description:Determine the difference in average morphine equivalent units between experimental and control group.
Outcome Type:Primary Outcome
Measure:Average Morphine Equivalent Units
Time Frame:30 days post-operation.
Safety Issues:False
Description:Determine the difference in average morphine equivalent units between experimental and control group.
Outcome Type:Secondary Outcome
Measure:Pain Score (10 point VAS)
Time Frame:Perioperative, 1 week post-operation, 1 week post-discharge, and 30 days post-operation.
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Post-operative Complications
Time Frame:30 days post-operation.
Safety Issues:False
Description:Incidence of postoperative complications between experimental and control group.
Outcome Type:Secondary Outcome
Measure:Narcotics-related Complications
Time Frame:30 days post-operation.
Safety Issues:False
Description:Incidence of narcotics-related complications between experimental and control group.
Outcome Type:Secondary Outcome
Measure:Inpatient Length of Stay
Time Frame:1 week post-operation.
Safety Issues:False
Description:Determine the difference of average inpatient length of stay between experimental and control group.
Outcome Type:Secondary Outcome
Measure:Inpatient Cost
Time Frame:1 week post-operation.
Safety Issues:False
Description:Determine the difference of average inpatient cost between experimental and control group.

Study Interventions

Intervention Type:Drug
Name:Gabapentin
Description:Use of Gabapentin peri- and post-operatively.
Arm Name:Intervention
Other Name:Neurontin
Intervention Type:Drug
Name:Placebo - Concentrate
Description:Use of sugar-free Placebo peri- and post-operatively.
Arm Name:Control

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Control
Description: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.
Study Arm Type:Experimental
Arm Name:Intervention
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.