Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps

Phase 2

Completed

• Conditions: Head and Neck Cancer; Free Tissue Transfer
• Interventions: Drug: Ropivicaine; Drug: Local Saline Infusion

• Registration Number: NCT03349034
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Procedures involved in this study include:

- Intraoperatively, following procurement of the fibula or scapula bone graft and at the time of surgical wound closure, all patients will receive the placement of a continuous infusion catheter into the donor site wound bed. The infusion reservoir will be connected to a catheter-based On-Q pump, and the catheter will be placed in the donor site. A stab incision separate from the surgical wound will be used to bring the catheter through the skin. Patients will be randomized to receive 6 ml/hr of 0.2% Ropivacaine or 6 ml/hr of normal saline via the infusion reservoir. The catheter will be left in place with continuous infusion for first 48 hours of the post-operative period. The catheters will be removed by the housestaff on POD2. There is minimal risk to removing the OnQ catheter. Any opening in the skin will be covered with gauze to allow primary healing. Solutions of saline and ropivacaine will be prepared and made available for infusion by the Mount Sinai Pharmacy. Solutions will be blinded, and identical in appearance. Patients will be assigned to ropivacaine or saline intervention by the research pharmacy through coded envelopes. Patients, physicians, nurses, and research personnel will be blinded to treatment assignment. Every 8 hours for the first 48 hours, patients will be asked to complete a visual analogue scale (VAS) for reporting their pain. The VAS will be performed six times over the course of the 48hrs. These will be performed during regular flap check monitoring, to ensure patients are not disrupted additional times throughout the day for this study. Patients will otherwise receive standard of care pain management, including Tylenol 650 q6hr standing as well as a dilaudid PCA set to low-dose, opioid naïve. On post-operative day 2 patient will receive a physical therapy evaluation.

Prior to discharge from the hospital, the study subjects will be asked to complete a brief survey (APS-POQ-R Pain Survey) regarding their experience, with regard to pain management.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-13
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2020-09-30
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Results First Posted: 2020-11-17
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Ropivicaine	Local Ropivicaine Infusion
Control Group	Local Saline Infusion	Local Saline Infusion

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain - Global Pain	8, 16, 24, 32, 40 and 48 hours	Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. 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. Full scale from 0-100, higher score indicates more pain.
Post-Operative Pain at Donor-Site	8, 16, 24, 32, 40 and 48 hours	Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. 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. Full scale from 0-100, higher score indicates more pain.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	48 hours	All subjects receive standing tylenol 650mg every 6 hours as well as a dilaudid PCA set for low-dose, opioid-naive patients for the first 48 hours post-operatively. Total opioid consumption for each subject during the first 48 hours is recorded measured in oral morphine equivalents (OME).
Range of Motion	48 hours	At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees
Distance Ambulated	48 hours	At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.
Strength	48 hours	At 48 hours all subjects received a physical therapy evaluation. Strength measured on a standard neurological 5 point scale: 0 = Complete Paralysis to 5 = Normal Power.
American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)	48 hours	Pain question on APS-POQ-R - A standardized pain satisfaction survey distributed to subjects at 48 hours rating their overall satisfaction with postoperative pain management. a 16-item questions measured on a 10-point numeric likert scale, with higher scores indicating more pain. Total range from 0 (no pain) to 200 (severe pain).

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States