Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

NCT03682367 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 1166778
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck; Narcotic Use

Keywords

Gabapentin; Narcotic; Cancer; Placebo

Outcome Measures

Primary Outcomes (3)

• Average Morphine Equivalent Units

  Determine the difference in average morphine equivalent units between experimental and control group.

  Perioperative.

• Average Morphine Equivalent Units

  Determine the difference in average morphine equivalent units between experimental and control group.

  1 week post-operation.

• Average Morphine Equivalent Units

  Determine the difference in average morphine equivalent units between experimental and control group.

  30 days post-operation.

Secondary Outcomes (5)

• Pain Score (10 Point VAS)

  Perioperative, 1 week post-operation, 1 week post-discharge, and 30 days post-operation.

• Post-operative Complications

  30 days post-operation.

• Narcotics-related Complications

  30 days post-operation.

• Inpatient Length of Stay

  1 week post-operation.

• Inpatient Cost

  1 week post-operation.

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

Gabapentin DRUG

Use of Gabapentin peri- and post-operatively.

Also known as: Neurontin, Gralise, Horizant

Intervention

Placebo - Concentrate DRUG

Use of sugar-free Placebo peri- and post-operatively.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early study termination was decided after several technical issues regarding study logistics and patient non-compliance lead to unreliable and uninterpretable data.

Results Point of Contact

• Title: Arnaud Bewley
• Organization: UC Davis Health

abewley@ucdavis.edu

9167342704

Study Officials

• Arnaud Bewley, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All staff involved including nursing, surgeons, pain management, participants and PI will be blinded. Unmasked personnel only include research pharmacy staff.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: December 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 6, 2020
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)