NCT03349034

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

Completed Phase 2 Results posted Last updated 17 November 2020

What this trial tests

Phase 2 trial testing Ropivicaine in Head and Neck Cancer in 24 participants. Completed in 30 September 2019.

Timeline

13 September 2017

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	24
Start date	13 September 2017
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Ropivicaine — full drug profile →
• Local Saline Infusion — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Free Tissue Transfer — all drugs for Free Tissue Transfer →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Head and Neck Cancer or Free Tissue Transfer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-Operative Pain at Donor-Site Primary · 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.

8 hour

Group	Value	95% CI
Saline Placebo	52.40	± 25.33
Ropivacaine	41.14	± 28.30

16 hour

Group	Value	95% CI
Saline Placebo	41.00	± 33.20
Ropivacaine	40.88	± 31.46

24 hour

Group	Value	95% CI
Saline Placebo	23.33	± 29.28
Ropivacaine	45.67	± 24.87

32 hour

Group	Value	95% CI
Saline Placebo	25.67	± 27.28
Ropivacaine	37.44	± 31.11

40 hour

Group	Value	95% CI
Saline Placebo	30.12	± 22.29
Ropivacaine	42.11	± 30.64

48 hour

Group	Value	95% CI
Saline Placebo	28.75	± 21.72
Ropivacaine	30.60	± 28.30

Post-Operative Pain - Global Pain Primary · 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.

8 hour

Group	Value	95% CI
Saline Placebo	44.00	± 28.55
Ropivacaine	40.14	± 32.25

16 hour

Group	Value	95% CI
Saline Placebo	27.50	± 23.18
Ropivacaine	26.56	± 27.03

24 hour

Group	Value	95% CI
Saline Placebo	31.83	± 21.25
Ropivacaine	41.56	± 30.33

32 hour

Group	Value	95% CI
Saline Placebo	24.17	± 25.91
Ropivacaine	35.67	± 32.39

40 hour

Group	Value	95% CI
Saline Placebo	21.88	± 20.36
Ropivacaine	33.60	± 28.76

48 hour

Group	Value	95% CI
Saline Placebo	20.38	± 13.43
Ropivacaine	37.40	± 35.50

Opioid Consumption Secondary · 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).

Group	Value	95% CI
Saline Placebo	119.75	± 145.92
Ropivacaine	91.20	± 132.14

Distance Ambulated Secondary · 48 hours

At 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.

Group	Value	95% CI
Saline Placebo	152	± 111.9
Ropivacaine	80	± 67.08

Strength Secondary · 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.

Group	Value	95% CI
Saline Placebo	2.67	± 0.82
Ropivacaine	2.20	± 1.10

American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R) Secondary · 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).

Group	Value	95% CI
Saline Placebo	6.0	± 2.39
Ropivacaine	4.3	± 1.34

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Local infusion of ropivacaine for pain control after osseous free flaps: Randomized controlled trial.
   Roof S, Ferrandino R, Eden C, Khelemsky Y, et al · · 2021 · cited 5× · PMID 33619855 · DOI 10.1002/hed.26562