Analgesia, Head and Neck Cancer
Conditions
Brief summary
This study will be a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.
Detailed description
ABSTRACT Objectives: To apply implementation science principles to optimize the delivery of multimodal analgesia to patients undergoing major head and neck oncologic surgeries including free flap reconstruction, to reduce variability in opioid administration and decrease the need for opioids. Methods: A pilot prospective randomized controlled trial (RCT #1) followed by a hybrid type 1 effectiveness-implementation pragmatic randomized controlled trial (RCT #2). RCT#1 included patients randomized to receive either scheduled acetaminophen and as needed opioids (control, Group 1) or scheduled acetaminophen, gabapentin, ketorolac, and as needed opioids (experimental, Group 2). The primary outcome was mean morphine milligram equivalents (MMEs) administered during the hospital stay. Secondary outcomes were hospital length of stay (LOS) and postoperative complications. We applied the principles of implementation science after identifying significant variability in healthcare professionals' approaches to administering opioids postoperatively during RCT#1. RCT#2, a hybrid type 1 effectiveness-implementation pragmatic trial, was designed to test the effectiveness of the intervention and the penetrance of the implementation strategy. Arm A received standard regimen of scheduled acetaminophen and as needed opioids. Arm B received scheduled gabapentin, ketorolac, a regional nerve block at the free tissue donor site, scheduled acetaminophen and as needed opioids. Primary outcome was mean MMEs administered during the hospital stay (0-3 and 0-7 days). Secondary outcomes were LOS, complications, and functional pain scores (ABCs). KEYWORDS: multimodal analgesia; head and neck; free flap reconstruction; dissemination and implementation LEVEL OF EVIDENCE: 1B, Randomized Clinical Trial
Interventions
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic. * Patients with a new H\&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.
Exclusion criteria
* Prior treatment for head and neck cancer. * Planned treatment with primary radiation or chemoradiation for their head and neck cancer. * Pregnant or lactating women. * Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively. * Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively. * Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes. * Patients with documented history of kidney or liver disease. * Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests. * Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Morphine Equivalents During Stay | Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7. | Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them. |
| Mean Morphine Equivalents | From day of index surgery to 1 year post-operatively. | Mean morphine equivalents prescribed outpatient after index surgery. Will be calculated after converting all opioids to morphine equivalents and then averaging them. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | At end of stay, number of post-operative days spent in the hospital was recorded for each patient. | Length of stay in days |
| Number of Patients With Post-operative Complications | Analyze the first 7 post-operative days to confirm number of patients with post-operative complications | Monitor chart/EMR for bleeding, acute kidney injury, etc. |
| Patient Pain Percentage Compared to Baseline | Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm. | Pain was measured on a Likert scale from 0 to 10 (i.e. 0 being the lowest and 10 being the greatest amount of pain). Baseline pain (P0) was measured on this scale for each patient in the preoperative setting. Pain was similarly assessed at regular intervals post-operatively during hospitalization (Pn). Patient pain percentage was subsequently defined as follows: { 100\*\[(P\_n/P\_0) -1\]│ n∈N, n≥1} Where: P\_0: the baseline (initial) measurement taken at time t=0. P\_n: the measurement taken at the nth time interval after baseline, where n∈N, n≥1 Interpretation of "pain percentage compared to baseline": * A value of 0% indicates no change from baseline pain * Negative values indicate lower pain than baseline * Positive values indicate higher pain than baseline * Therefore, lower values represent a better outcome and higher values represent a worse outcome |
| Patient Pain Assessment Percentage | Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days. | Each of the domain of ABC pain index is weighted (mult\_D) based on relative importance. For each domain D ∈{sleep, lying, sitting, oob, walk}, let: D\_able∈{1,2,3}, (1 = able with pain; 2 = unable due to pain; 3 = unable for other reasons) D\_pain∈\[0, 5\] (reported pain score) Then if: D\_able = 1 numerator\_D = D\_pain × mult\_D denominator\_D = 1 +(5×mult\_D) D\_able=2 numerator\_D = 1 + (5×mult\_D) denominator\_D= 1 + (5×mult\_D ) D\_able=3 numerator\_D = 1 denominator\_D = 1 For the site-specific domains D ∈{h\&n,flap,graft}, let: D\_present∈{1,2} (1=present; 2=absent) D\_pain∈\[0, 5\] (reported pain score) Then if: D\_present=1: numerator\_D = D\_pain × mult\_D denominator\_D = 5 × mult\_D D\_present=2: numerator\_D = 0 denominator\_D = 0 Patient Pain Assessment Percentage: ABC\_numerator = sum(numerator\_D) ABC\_denominator = sum(denominator\_D) ABC\_percentage = ABC\_numerator / ABC\_denominator This ranges from 0-100%. Lower values are better, higher values are worse. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Shnayder, MD
KUMC
Participant flow
Recruitment details
prospective
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 69.4 years STANDARD_DEVIATION 12.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
None listed