Postoperative Pain ControlPhase 3NCT04176419
Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
A Phase 3 study testing Ketamine, Lidocaine and Acetaminophen in people with Postoperative Pain Control and Opioid Consumption, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Control, Opioid Consumption
- What is being tested?
- Ketamine, Lidocaine and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 23 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing head \& neck free flap reconstruction at the Cleveland Clinic Main Campus
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study
- Subjects receiving any other investigational agents
- Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days
- Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days
- Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months
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- Pregnancy
- Contraindication to lidocaine (heart block, heart failure with EF < 30%) as determined by history of Congestive Heart Failure, or as determined by preoperative evaluation for surgical clearance
- In the opinion of the investigator, subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction
The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.
Read the detailed description
This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.
- Conditions
- Postoperative Pain Control, Opioid Consumption
- Being tested
- Ketamine, Placebo Ketamine, Lidocaine, Placebo Lidocaine, Acetaminophen
- Keywords
- Head & neck cancer, Microvascular free flap reconstruction
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine Hydrochloride, Ketamine Hydrochloride Injection, USP
0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
Placebo KetamineDrug
0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
LidocaineDrug
Also called Lidocaine Hydrochloride and 5% dextrose, lidocaine hydrochloride injection
1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
Placebo LidocaineDrug
1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
AcetaminophenDrug
Also called Paracetamol, Tylenol, N-acetyl-para-aminophenol, APAP
1,000 mg orally at time of check-in to the preoperative unit
Placebo AcetaminophenDrug
1,000 mg orally at time of check-in to the preoperative unit
GabapentinDrug
Also called Neurontin
600 mg orally at time of check in to the preoperative unit
Placebo GabapentinDrug
600 mg orally at time of check in to the preoperative unit
CelecoxibDrug
Also called Celebrex
200 mg orally at time of check in to the preoperative unit
Placebo CelecoxibDrug
200 mg orally at time of check in to the preoperative unit
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Perioperative intervention (preoperative acetaminophen, gabapentin, and celecoxib and intraoperative ketamine and lidocaine).
The Investigational Drug Service will mix and prepare the study medications necessary for each participant. An Investigational Drug Service staff member will deliver the oral medications to the nursing team in the preoperative holding unit and the IV medications to the anesthesia team in the OR unit. Receives: Drug: Ketamine; Drug: Lidocaine; Drug: Acetaminophen; Drug: Gabapentin; Drug: Celecoxib |
| Control Group | Placebo comparator | Perioperative placebo
Placebo oral drugs will be encapsulated versions provided by the Investigational Drug Service and will appear identical to the interventional oral drugs. Placebo IV infusions will be prepared by Investigational Drug Service as per institutional guidelines and will appear identical to the interventional IV drugs. Receives: Drug: Placebo Ketamine; Drug: Placebo Lidocaine; Drug: Placebo Acetaminophen; Drug: Placebo Gabapentin; Drug: Placebo Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption measured in daily morphine equivalent
Total opioid consumption measured in daily morphine equivalent
Measured: at 48 hours postop
Pain levels on Visual Analog Scale (VAS)
Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)
Measured: Pre-Op, 24 hours postop, and 48 hours postop
Secondary outcomes (3)
Average Opioid Related Symptom Distress Scale (ORSDS) scores
Average Opioid Related Symptom Distress Scale (ORSDS) scores
The OR-SDS is used to assess subject-reported levels of severity concerning 12 symptoms known to be associated with opioid medication usage. Symptom frequency, severity, and how bothersome symptom was is rated from 1-4 with higher . The average score for each symptom is calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).
Measured: at 96 hours after surgery, and at discharge (an average of 1 week)
Average Patient satisfaction with pain management scores
Average scores for Internally-developed "patient satisfaction with pain management" questionnaire.
Domains include pain expected vs experienced, frequency of severe pain, promptness of care team, effectiveness of treatment, and future preferences
Domain scores range from 1-5 with higher scores mean worse outcomes (more severe pain, poor quality of care)
Domains are distinct and are not summarized with a "total"score.
Measured: at the time of discharge (an average of 1 week)
Time to first flatulence and defecation
Time to first flatulence and defecation from end of surgical case
Measured: an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start17 Jan 2020
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Why it stopped: Workforce shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ControlStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Ku, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176419
- Sponsor's protocol ID
- CASE6319
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT04176419
- Acronym / sponsor ID
- CASE6319
- Conditions
- Postoperative Pain Control, Opioid Consumption
- Keywords
- Head & neck cancer, Microvascular free flap reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Workforce shortage
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.
Detailed description
This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Ketamine, Drug: Lidocaine, Drug: Acetaminophen, Drug: Gabapentin, Drug: CelecoxibPerioperative intervention (preoperative acetaminophen, gabapentin, and celecoxib and intraoperative ketamine and lidocaine). The Investigational Drug Service will mix and prepare the study medications necessary for each participant. An Investigational Drug Service staff member will deliver the oral medications to the nursing team in the preoperative holding unit and the IV medications to the anesthesia team in the OR unit. |
| Control Group | Placebo comparator | Drug: Placebo Ketamine, Drug: Placebo Lidocaine, Drug: Placebo Acetaminophen, Drug: Placebo Gabapentin, Drug: Placebo CelecoxibPerioperative placebo Placebo oral drugs will be encapsulated versions provided by the Investigational Drug Service and will appear identical to the interventional oral drugs. Placebo IV infusions will be prepared by Investigational Drug Service as per institutional guidelines and will appear identical to the interventional IV drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing head \& neck free flap reconstruction at the Cleveland Clinic Main Campus
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study
- Subjects receiving any other investigational agents
- Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days
- Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketamine Hydrochloride, Ketamine Hydrochloride Injection, USP0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes. | Drug | Treatment Group |
| Placebo Ketamine0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes. | Drug | Control Group |
| LidocaineAlso: Lidocaine Hydrochloride and 5% dextrose, lidocaine hydrochloride injection1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case | Drug | Treatment Group |
| Placebo Lidocaine1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case | Drug | Control Group |
| AcetaminophenAlso: Paracetamol, Tylenol, N-acetyl-para-aminophenol, APAP1,000 mg orally at time of check-in to the preoperative unit | Drug | Treatment Group |
| Placebo Acetaminophen1,000 mg orally at time of check-in to the preoperative unit | Drug | Control Group |
| GabapentinAlso: Neurontin600 mg orally at time of check in to the preoperative unit | Drug | Treatment Group |
| Placebo Gabapentin600 mg orally at time of check in to the preoperative unit | Drug | Control Group |
| CelecoxibAlso: Celebrex200 mg orally at time of check in to the preoperative unit | Drug | Treatment Group |
| Placebo Celecoxib200 mg orally at time of check in to the preoperative unit | Drug | Control Group |
Primary outcome
Total opioid consumption measured in daily morphine equivalent
Time frame: at 48 hours postop
Total opioid consumption measured in daily morphine equivalent
Pain levels on Visual Analog Scale (VAS)
Time frame: Pre-Op, 24 hours postop, and 48 hours postop
Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)
3 secondary outcomes
Average Opioid Related Symptom Distress Scale (ORSDS) scores
Time frame: at 96 hours after surgery, and at discharge (an average of 1 week)
Average Patient satisfaction with pain management scores
Time frame: at the time of discharge (an average of 1 week)
Time to first flatulence and defecation
Time frame: an average of 7 days
Results and safety
The study was stopped early (reason given: Workforce shortage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Ku, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine, Lidocaine and Acetaminophen in people with Postoperative Pain Control and Opioid Consumption, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Workforce shortage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption measured in daily morphine equivalent (time frame: at 48 hours postop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.