Multimodal Pain Study in Free Flap Patients

Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study

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.

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

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 .