A Phase 2 interventional study of Ropivicaine and Local Saline Infusion in Head and Neck Cancer and Free Tissue Transfer, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Supportive care
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.
Procedures involved in this study include:
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 24 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
This includes osseocutaneous tissue from fibula and scapula
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local Ropivicaine Infusion
Drug: Ropivicaine
Local Saline Infusion
Drug: Local Saline Infusion
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.
Post-Operative Pain at Donor-Site
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.
Time frame: 8, 16, 24, 32, 40 and 48 hours
Post-Operative Pain - Global Pain
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.
Time frame: 8, 16, 24, 32, 40 and 48 hours
Opioid Consumption
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).
Time frame: 48 hours
Range of Motion
At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees
Time frame: 48 hours
Distance Ambulated
At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.
Time frame: 48 hours
Strength
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.
Time frame: 48 hours
American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)
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).
Time frame: 48 hours
Participants undergoing osseocutaneous fibula or scapular tip free flaps for head and neck reconstructionwere enrolled from September 2017 and September 2019.
| Milestone | Saline Placebo | Ropivacaine |
|---|---|---|
| Started | 12 | 12 |
| Completed | 8 | 10 |
| Not completed | 4 | 2 |
| Withdrew: Catheters dislodged during transport | 2 | 0 |
| Withdrew: Intubated for >48 hrs following surgery | 1 | 1 |
| Withdrew: Soft tissue flap used | 1 | 0 |
| Withdrew: Other | 0 | 1 |
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.
| score on a scale | Saline Placebo | Ropivacaine |
|---|---|---|
| 8 hour | 52.40 ± 25.33 | 41.14 ± 28.30 |
| 16 hour | 41.00 ± 33.20 | 40.88 ± 31.46 |
| 24 hour | 23.33 ± 29.28 | 45.67 ± 24.87 |
| 32 hour | 25.67 ± 27.28 | 37.44 ± 31.11 |
| 40 hour | 30.12 ± 22.29 | 42.11 ± 30.64 |
| 48 hour | 28.75 ± 21.72 | 30.60 ± 28.30 |
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.
| score on a scale | Saline Placebo | Ropivacaine |
|---|---|---|
| 8 hour | 44.00 ± 28.55 | 40.14 ± 32.25 |
| 16 hour | 27.50 ± 23.18 | 26.56 ± 27.03 |
| 24 hour | 31.83 ± 21.25 | 41.56 ± 30.33 |
| 32 hour | 24.17 ± 25.91 | 35.67 ± 32.39 |
| 40 hour | 21.88 ± 20.36 | 33.60 ± 28.76 |
| 48 hour | 20.38 ± 13.43 | 37.40 ± 35.50 |
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).
| OME | Saline Placebo | Ropivacaine |
|---|---|---|
| Opioid Consumption | 119.75 ± 145.92 | 91.20 ± 132.14 |
At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees
No measurements were reported for this outcome.
At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.
| feet | Saline Placebo | Ropivacaine |
|---|---|---|
| Distance Ambulated | 152 ± 111.9 | 80 ± 67.08 |
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.
| score on a scale | Saline Placebo | Ropivacaine |
|---|---|---|
| Strength | 2.67 ± 0.82 | 2.20 ± 1.10 |
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).
| score on a scale | Saline Placebo | Ropivacaine |
|---|---|---|
| American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R) | 6.0 ± 2.39 | 4.3 ± 1.34 |
Collected over 48 hours post surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Ropivacaine | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Mean | 65.1 ± 11.6 | 67.1 ± 13.7 | 66.2 ± 12.6 |
| Sex: Female, Male(Participants) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 8 | 8 | 16 |
| Race and Ethnicity Not Collected(Participants) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index(kg/m^2) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Mean | 27.2 ± 4.81 | 28.7 ± 4.39 | 28.0 ± 4.51 |
| ASA Physical Status Classification System(units on a scale) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Mean | 2.88 ± 0.35 | 3.10 ± 0.32 | 3.0 ± 0.34 |
| Pack Years(cigarettes per day for 1 year) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Mean | 7.75 ± 15.1 | 7.30 ± 10.1 | 7.5 ± 12.2 |
| Smoking at Diagnosis(Participants) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Count of participants | 0 | 1 | 1 |
| Number of participants with Alcohol Abuse(Participants) | Saline Placebo | Ropivacaine | Total |
|---|---|---|---|
| Count of participants | 1 | 0 | 1 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Sep 2019, 24 months.
Results were first posted in Nov 2020, 1 year 1 month after primary completion.
Of 215 non-industry phase 2 interventional studies under Head and Neck Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 84. This study's 24 months is below that.
Counting every sponsor, half of 259 studies reached it within 51 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Icahn School of Medicine at Mount Sinai →