Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | December 31, 2018 |
| End Date: | November 1, 2022 |
Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial
The purpose of this study is to evaluate and reduce pain and improve quality of life in
patients being treated for head and neck cancer with primary tumor resection and bilateral
neck dissections. Patients will be randomly assigned to receive either pre-operative
pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which
medication patients receive, and all patients will receive the same postoperative pain
medication regimen with appropriate pain treatment as needed. Patients will be asked to fill
out surveys prior to surgery, while in the hospital after surgery, and at each follow-up
appointment for up to 24 months.
patients being treated for head and neck cancer with primary tumor resection and bilateral
neck dissections. Patients will be randomly assigned to receive either pre-operative
pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which
medication patients receive, and all patients will receive the same postoperative pain
medication regimen with appropriate pain treatment as needed. Patients will be asked to fill
out surveys prior to surgery, while in the hospital after surgery, and at each follow-up
appointment for up to 24 months.
In this study, we will utilize single-dose pre-operative administration of Lyrica
(pregabalin) compared to patients who will be administered a pre-operative single-dose
placebo. Pregabalin is a non-narcotic GABA analogue that has been shown to be effective for
the treatment of pain associated with a variety of medical conditions. Prior studies have
investigated the use of single-dose pre-operative pregabalin for analgesia in acute dental,
gynecologic, endoscopic thyroidectomy, and nasal septoplasty surgical pain with encouraging
results demonstrating improved overall pain scores and decreased post-operative use of
narcotics. Pregabalin's use for peri-operative analgesia in head and neck cancer surgery has
not been evaluated.
Patients who enroll in the study will be randomly assigned by chance to receive either a
single pre-operative 150 milligram dose of pregabalin (Lyrica) or placebo in the
pre-operative holding area prior to proceeding with surgery. Lyrica is a non-narcotic pain
medication that has been shown to promote good control of nerve-related pain in patients.
Patients who agree to enroll in the study will be asked to fill out separate questionnaires
to evaluate pain and quality of life preoperatively and post-operatively.
Participants will be asked to fill out four separate questionnaires to evaluate pain and
quality of life pre-operatively. Patients will be administered their respective medication,
either placebo or single-dose 150 milligram concealed capsule of pregabalin, by mouth in the
pre-operative holding area prior to surgery. While in the hospital after surgery, patients
will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned
treatment of pain will include the option of requesting oxycodone on an as-needed basis every
four hours and IV morphine for breakthrough pain. Surveys will be administered and collected
on a daily basis while patients are in the hospital. If patients are already utilizing other
non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic
pain medications (Neurontin), they will be allowed to continue these medications while
inpatient provided there are no changes in dosing.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed
oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow
up. Follow up visits will occur one week after discharge, four weeks after discharge, and
then every three months until completion of the two year study period.
(pregabalin) compared to patients who will be administered a pre-operative single-dose
placebo. Pregabalin is a non-narcotic GABA analogue that has been shown to be effective for
the treatment of pain associated with a variety of medical conditions. Prior studies have
investigated the use of single-dose pre-operative pregabalin for analgesia in acute dental,
gynecologic, endoscopic thyroidectomy, and nasal septoplasty surgical pain with encouraging
results demonstrating improved overall pain scores and decreased post-operative use of
narcotics. Pregabalin's use for peri-operative analgesia in head and neck cancer surgery has
not been evaluated.
Patients who enroll in the study will be randomly assigned by chance to receive either a
single pre-operative 150 milligram dose of pregabalin (Lyrica) or placebo in the
pre-operative holding area prior to proceeding with surgery. Lyrica is a non-narcotic pain
medication that has been shown to promote good control of nerve-related pain in patients.
Patients who agree to enroll in the study will be asked to fill out separate questionnaires
to evaluate pain and quality of life preoperatively and post-operatively.
Participants will be asked to fill out four separate questionnaires to evaluate pain and
quality of life pre-operatively. Patients will be administered their respective medication,
either placebo or single-dose 150 milligram concealed capsule of pregabalin, by mouth in the
pre-operative holding area prior to surgery. While in the hospital after surgery, patients
will be given a regimen of scheduled acetaminophen 650 milligrams every 6 hours. Planned
treatment of pain will include the option of requesting oxycodone on an as-needed basis every
four hours and IV morphine for breakthrough pain. Surveys will be administered and collected
on a daily basis while patients are in the hospital. If patients are already utilizing other
non-opioid pain medications like muscle relaxers (Flexeril, baclofen, etc.), or neuropathic
pain medications (Neurontin), they will be allowed to continue these medications while
inpatient provided there are no changes in dosing.
Patients will be discharged home on a seven-day course of acetaminophen with as-needed
oxycodone. Outcomes surveys will then be collected at each subsequent post-operative follow
up. Follow up visits will occur one week after discharge, four weeks after discharge, and
then every three months until completion of the two year study period.
Inclusion Criteria:
- English-speaking patients who are greater than eighteen years of age with a known
diagnosis of head and neck cancer and are planned to undergo surgery with bilateral
neck dissections will be eligible for this study.
Exclusion Criteria:
- Patients with a history of preoperative narcotic use for conditions unrelated to their
head and neck cancer will be excluded.
- Patients younger than eighteen years of age, patients with previous severe adverse
reaction to pregabalin (Lyrica), patients with a history of angioedema, and pregnant
patients will be excluded from this study.
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