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Anesthesia, LocalEarly Phase 1NCT03906838

Regional Anesthesia Block in Fibula Free Flap Reconstruction

A Early Phase 1 study testing Ropivacaine injection in people with Anesthesia, Local and Surgery, run by University of Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Local, Surgery, Opioid Use
What is being tested?
Ropivacaine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 30 Nov 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
  • Subjects undergoing primary or secondary reconstruction

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

Other trials in United States

About this study

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

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.

Being tested
Ropivacaine injection
Medical subject headings
Pain, Postoperative, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine injectionDrug

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

Study groups in NCT03906838
Study groupRoleWhat they receive
Regional Nerve BlockExperimentalSubjects 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.
Receives: Drug: Ropivacaine injection
No Regional Nerve BlockNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 72 hours (3 days) post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2019
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion30 Nov 2020 (estimated)

Why it stopped: funding not obtained

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03906838
Sponsor's protocol ID
IRB201900883
Status last verified
Jul 2019
First submitted
5 Apr 2019
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21704871

  • Werner MU, Soholm L, Rotboll-Nielsen P, Kehlet H. Does an acute pain service improve postoperative outcome? Anesth Analg. 2002 Nov;95(5):1361-72, table of contents. doi: 10.1097/00000539-200211000-00049. No abstract available.

    PubMed 12401627

  • 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. doi: 10.1001/jamainternmed.2013.12711.

    PubMed 24589873

  • 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.

    PubMed 21482846

  • Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006 Sep;15(9):618-27. doi: 10.1002/pds.1276.

    PubMed 16862602

  • 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.

    PubMed 19796521

  • 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. doi: 10.1067/mhn.2000.104946.

    PubMed 10964311

  • 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.

    PubMed 21147547

  • Bianchini C, Malago 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.

    PubMed 27196072

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

    PubMed 26509324

  • 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. doi: 10.1001/jama.290.18.2455.

    PubMed 14612482

  • 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.

    PubMed 18211990

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ropivacaine injection in people with Anesthesia, Local and Surgery, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption (time frame: 72 hours (3 days) post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03906838, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.

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