Clinical trial · Interventional
Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
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
NCT04176419CI-TRIAL-00082483terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Workforce shortage
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid Consumption | — | UNRESOLVED | — |
| Postoperative Pain Control | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Celecoxib | Drug | Celecoxib | ALIAS |
| Gabapentin | Drug | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
| Placebo Acetaminophen | Drug | — | UNRESOLVED |
| Placebo Celecoxib | Drug | — | UNRESOLVED |
| Placebo Gabapentin | Drug | — | UNRESOLVED |
| Placebo Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- 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.
- interventionNames
- Drug: Ketamine
- Drug: Lidocaine
- Drug: Acetaminophen
- Drug: Gabapentin
- Drug: Celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.