Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean morphine equivalents for Arm A
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 .
研究组 & 干预措施
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.
干预措施: Tylenol (Drug)
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.
干预措施: Oxycodone (Drug)
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.
干预措施: Morphine (Drug)
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
干预措施: Tylenol (Drug)
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
干预措施: Oxycodone (Drug)
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
干预措施: Morphine (Drug)
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
干预措施: Gabapentin (Drug)
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
干预措施: toradol (Drug)
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
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Mean morphine equivalents for Arm A
时间窗: 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
时间窗: 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 During Stay
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Length of Stay(At end of stay, number of post-operative days spent in the hospital was recorded for each patient.)
- Number of Patients With Post-operative Complications(Analyze the first 7 post-operative days to confirm number of patients with post-operative complications)
- 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.)
- 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.)