Regional Anesthesia Block in Fibula Free Flap Reconstruction

Surgery Clinical Trial

Official title:

Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03906838
• Other study ID #: IRB201900883
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Head and Neck Neoplasms
• Opioid Use
• Pain, Postoperative
• Surgery

Intervention

Drug:
• Ropivacaine injection
Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.

Locations

Country	Name	City	State
United States	University of Florida Health Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bianchini C, Malagò M, Crema L, Aimoni C, Matarazzo T, Bortolazzi S, Ciorba A, Pelucchi S, Pastore A. Post-operative pain management in head and neck cancer patients: predictive factors and efficacy of therapy. Acta Otorhinolaryngol Ital. 2016 Apr;36(2):91-6. doi: 10.14639/0392-100X-499. Epub 2016 Apr 29. — View Citation

Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. Review. — View Citation

Chen 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. — View Citation

Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373. Review. — View Citation

Gomes 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. — View Citation

Gwira 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. — View Citation

Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006 Sep;15(9):618-27. — View Citation

Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. Review. — View Citation

Talmi 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. — View Citation

Warner 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. — View Citation

Werner MU, Søholm L, Rotbøll-Nielsen P, Kehlet H. Does an acute pain service improve postoperative outcome? Anesth Analg. 2002 Nov;95(5):1361-72, table of contents. Review. — View Citation

Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Defined by the research team as the subjects' morphine equivalent dose at 72 hours (3 days) post-operatively. The postoperative period commences at extubation.	72 hours (3 days) post-operatively

External Links

•   American Society of Regional Anesthesia and Pain Management. Risks and Benefits of Regional Anesthesia.
•   Compressed Mortality File. National Center for Health Statistics.
•   PROSPECT website