Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study
Overview
- Phase
- Phase 4
- Intervention
- Tylenol
- Conditions
- Head and Neck Cancer
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean morphine equivalents for Arm A
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will be fashioned as 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.
Investigators
Eligibility Criteria
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 .
Arms & Interventions
Standard of Care A
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: * Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs * Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): * 0-3: no prn meds, reassurance, listen to music, watch TV. * 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. * 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Intervention: Tylenol
Standard of Care A
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: * Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs * Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): * 0-3: no prn meds, reassurance, listen to music, watch TV. * 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. * 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Intervention: Oxycodone
Standard of Care A
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: * Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs * Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): * 0-3: no prn meds, reassurance, listen to music, watch TV. * 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. * 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Intervention: Morphine
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: Tylenol
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: Oxycodone
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: Morphine
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: Gabapentin
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: toradol
Standard of Care B
Arm B, will include: * Arm A description with addition.. * Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days * Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively * Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Mean morphine equivalents for Arm A
Time Frame: During the study period of approximately 1 year
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Mean morphine equivalents for Arm B
Time Frame: During the study period of approximately 1 year
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Secondary Outcomes
- Post-operative complications(Analyze the first 7 post-operative days)
- Length of stay(Analyze the first 7 post-operative days but take note of how long they stayed.)
- Pain assessment for patients(The ABC pain scale will be given once daily for the patient to fill out for the first seven days.)