Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps
Condition: Head and Neck Cancer; Free Tissue Transfer
MeSH terms: Head and Neck Neoplasms
Intervention: Ropivicaine; Local Saline Infusion
Intervention description: Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.; Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a double-blind prospective randomized placebo controlled trial wherein patients undergoing osseocutaneous free flap surgery are randomized to receive continuous infusion of Ropivacaine or normal saline (placebo) via local infusion catheter, which will be placed intraoperatively at the time of donor site closure. Outcomes are tracked and assessed for the first 48 hours post-operatively - median post-operative pain assessed via VAS every 8 hours, total analgesic used (all patients receive Tylenol 650 and dilaudid PCA post-operatively), physical therapy outcomes assessed on post-operative day two, and a patient satisfaction survey.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Local anesthetics; Randomized Control Trial; Free tissue transfer; Head and neck; Microvascular; Postoperative Pain

Summary:

      Head and neck oncologic surgery often requires the use of free tissue transfer, or
      microvascular reconstruction, to reconstruct defects created by tumor resections. Although
      there are several techniques for the reconstruction of defects, resection of large tumors
      leave defects that require the transfer of vascularized tissue from one part of the body to
      repair the defect. For example, the removal of a segment of diseased mandible requires free
      tissue transfer containing the component parts - skin, muscle, and bone - to reconstruct the
      deficit created by the resection of the tumor. Over the years, microvascular surgeons have
      focused their attention on maximizing the success of these technically difficult surgeries.
      However, now, with free flap reconstruction rates in excess of 95%, surgeons are afforded the
      opportunity to turn their focus toward the morbidities associated with these surgeries. While
      much has been published about donor site wound healing, pain control in the post-operative
      period has largely been neglected in the head and neck reconstruction literature. Systemic
      analgesia with opioids is standard of care, which has been shown to lead to increased
      confusion, significantly increased length of stay and increased risk of pulmonary
      complications. In addition, it has been shown that early mobilization and optimal wound care
      can decrease donor site morbidity.

      In this study the clinical team aims to better control donor site pain utilizing local,
      targeted analgesia to relieve pain at the donor site for osseocutaneous free-flaps. To reduce
      confounding and bias, the study will be a double-blind prospective randomized placebo
      controlled trial wherein patients undergoing osseocutaneous free flap surgery will be
      randomized to receive continuous infusion of ropivacaine or normal saline (placebo) via local
      continuous infusion catheter, which will be placed intraoperatively at the time of donor site
      closure. Patients' pain will be monitored for the first 48hrs after surgery. Donor site and
      global pain at rest will be evaluated every 8 hours for the first two postoperative days
      using a visual analogue pain scale (VAS). Essentially, there is a 100 millimeter line drawn
      on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking
      the right end of the line. Subjects mark with a pen along the line where pain is felt fits
      along that continuum. A researcher then measures how far along the line that mark is placed
      and then it is recorded. Median daily opiate use via PCA will also be tracked. Donor
      site-specific range of motion and strength will be assessed with a formal physical therapy
      evaluation on post-operative day 2 or soonest non-holiday weekday. Information on patient
      satisfaction, time to ambulation, and length of stay will also be collected. Subgroup
      analysis will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving osseocutaneous free tissue transfer regardless of the indication
             for free tissue transfer.

        This includes osseocutaneous tissue from fibula and scapula

          -  Age ≥ 18

        Exclusion Criteria:

          -  Patients unable to understand the research protocol and/or provide informed consent

          -  Patients under the age of 18

          -  Patients with a history of allergic reaction to Ropivacaine or other local amide
             anesthetics

          -  Patients whose participation in this trial would require exclusion from participation
             in another clinical research trial related to the patient's malignant diagnosis.

          -  Patients with previous pain disorders or drug abuse requiring chronic narcotic use.

          -  Vulnerable populations (adults unable to consent, individuals who are not yet adults,
             wards of the state, prisoners)