Clinical trial NCT03349034: Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps
Official title: Role of Continuous Local Infusion of Ropivacaine for Post-Operative Pain Management in Patients Receiving Osseocutaneous Free Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Free Tissue Transfer
Keywords: Local anesthetics
Randomized Control Trial
Free tissue transfer
Head and neck
Microvascular
Postoperative Pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Post-Operative Pain at Donor-Site
timeFrame: 8, 16, 24, 32, 40 and 48 hours
measure: Post-Operative Pain - Global Pain
timeFrame: 8, 16, 24, 32, 40 and 48 hours
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 48 hours
measure: Range of Motion
timeFrame: 48 hours
measure: Distance Ambulated
timeFrame: 48 hours
measure: Strength
timeFrame: 48 hours
measure: American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)
timeFrame: 48 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eric Genden, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Brett Miles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumenthal S, Dullenkopf A, Rentsch K, Borgeat A. Continuous infusion of ropivacaine for pain relief after iliac crest bone grafting for shoulder surgery. Anesthesiology. 2005 Feb;102(2):392-7. doi: 10.1097/00000542-200502000-00023.
citation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
citation: Oderda GM, Said Q, Evans RS, Stoddard GJ, Lloyd J, Jackson K, Rublee D, Samore MH. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007 Mar;41(3):400-6. doi: 10.1345/aph.1H386. Epub 2007 Mar 6.
citation: Singh K, Samartzis D, Strom J, Manning D, Campbell-Hupp M, Wetzel FT, Gupta P, Phillips FM. A prospective, randomized, double-blind study evaluating the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after spinal arthrodesis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2477-83. doi: 10.1097/01.brs.0000186323.11285.b1.
citation: Roof S, Ferrandino R, Eden C, Khelemsky Y, Teng M, Genden E, DeMaria S Jr, Miles BA. Local infusion of ropivacaine for pain control after osseous free flaps: Randomized controlled trial. Head Neck. 2021 Apr;43(4):1063-1072. doi: 10.1002/hed.26562. Epub 2021 Feb 23.