Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

Opioid Consumption Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176419
• Other study ID #: CASE6319
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 17, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption
• Pain, Postoperative
• Postoperative Pain Control

Intervention

Drug:
• Ketamine
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 Ketamine
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.
• Lidocaine
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 Lidocaine
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
• Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
• Placebo Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
• Gabapentin
600 mg orally at time of check in to the preoperative unit
• Placebo Gabapentin
600 mg orally at time of check in to the preoperative unit
• Celecoxib
200 mg orally at time of check in to the preoperative unit
• Placebo Celecoxib
200 mg orally at time of check in to the preoperative unit

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption measured in daily morphine equivalent	Total opioid consumption measured in daily morphine equivalent	at 48 hours postop
Primary	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)	Pre-Op, 24 hours postop, and 48 hours postop
Secondary	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).	at 96 hours after surgery, and at discharge (an average of 1 week)
Secondary	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.	at the time of discharge (an average of 1 week)
Secondary	Time to first flatulence and defecation	Time to first flatulence and defecation from end of surgical case	an average of 7 days