Clinical trial · Interventional
Regional Anesthesia Block in Fibula Free Flap Reconstruction
Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding not obtained
Summary
Brief summary (as posted)
Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia, Local | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Opioid Use | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropivacaine injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regional Nerve Block
- description
- Subjects in the regional anesthesia cohort will have a regional anesthesia block and/or catheter placement administered according to current hospital policies and our established standard of care.
- interventionNames
- Drug: Ropivacaine injection
- type
- NO_INTERVENTION
- label
- No Regional Nerve Block
- description
- Subjects in the no regional anesthesia cohort will not get pre-operative regional anesthesia, and their surgery and anesthesia will be performed according to normal policies and standard of care in our hospital.
Primary outcomes (1)
- measure
- Opioid consumption
- timeFrame
- 72 hours (3 days) post-operatively
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects undergoing microvascular fibula free flap reconstruction of the head and neck * Subjects undergoing primary or secondary reconstruction Exclusion Criteria: * Subjects needing elevation of care to the intensive care unit due to remaining intubated for extended period of time or other complications during the peri or post operative period * Subjects with surgical complications requiring significant alteration of the treatment plan o Subjects requiring a return to the operating room during admission will be excluded, unless it is for a procedure not related to the original surgery occurring after post op day 3, such as a gastrostomy tube or long term IV access. * Subjects with true allergies to the study drugs * Subjects undergoing reconstruction with more than 1 free flap, or with the use of any additional regional flaps * History of substance dependence or enrollment in a pain management program * Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin. * Subjects who do not stay in the hospital for at least 4 days post operatively * Subjects requiring anticoagulation will not require modifications prior to receiving regional anesthesia. * Inability to properly place catheter or administer the regional anesthesia
References
Publications (12)
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- BACKGROUNDGwira Baumblatt JA, Wiedeman C, Dunn JR, Schaffner W, Paulozzi LJ, Jones TF. High-risk use by patients prescribed opioids for pain and its role in overdose deaths. JAMA Intern Med. 2014 May;174(5):796-801. doi: 10.1001/jamainternmed.2013.12711. PMID 24589873
- BACKGROUNDGomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. Arch Intern Med. 2011 Apr 11;171(7):686-91. doi: 10.1001/archinternmed.2011.117. PMID 21482846
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- BACKGROUNDWarner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. 2009 Sep;(22):1-8. PMID 19796521
- BACKGROUNDTalmi YP, Horowitz Z, Pfeffer MR, Stolik-Dollberg OC, Shoshani Y, Peleg M, Kronenberg J. Pain in the neck after neck dissection. Otolaryngol Head Neck Surg. 2000 Sep;123(3):302-6. doi: 10.1067/mhn.2000.104946. PMID 10964311
- BACKGROUNDChen SC, Liao CT, Chang JT. Orofacial pain and predictors in oral squamous cell carcinoma patients receiving treatment. Oral Oncol. 2011 Feb;47(2):131-5. doi: 10.1016/j.oraloncology.2010.11.004. Epub 2010 Dec 13.