Clinical trial · Interventional
Multimodal Pain Study in Free Flap Patients
Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine | Drug | — | UNRESOLVED |
| Gabapentin | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
| Oxycodone | Drug | — | UNRESOLVED |
| toradol | Drug | — | UNRESOLVED |
| Tylenol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care A
- description
- 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.
- interventionNames
- Drug: Tylenol
- Drug: Oxycodone
- Drug: Morphine
- type
- EXPERIMENTAL
- label
- Standard of Care B
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 .
References
Publications (0)
Data not yet available