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

NCT03349034 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 17-1391
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Free Tissue Transfer

Keywords

Local anesthetics; Randomized Control Trial; Free tissue transfer; Head and neck; Microvascular; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8, 16, 24, 32, 40 and 48 hours

Secondary Outcomes (5)

• Opioid Consumption

  48 hours

• Range of Motion

  48 hours

• Distance Ambulated

  48 hours

• Strength

  48 hours

• American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)

  48 hours

Study Arms (2)

Test Group

EXPERIMENTAL

Local Ropivicaine Infusion

Drug: Ropivicaine

Control Group

PLACEBO COMPARATOR

Local Saline Infusion

Drug: Local Saline Infusion

Interventions

Ropivicaine DRUG

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.

Test Group

Local Saline Infusion DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving osseocutaneous free tissue transfer regardless of the indication for free tissue transfer.
• This includes osseocutaneous tissue from fibula and scapula
• Age ≥ 18

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10129, United States

Location

Related Publications (5)

• 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.

  PMID: 15681956 BACKGROUND

• 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.

  PMID: 23392233 BACKGROUND

• 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.

  PMID: 17341537 BACKGROUND

• 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.

  PMID: 16284583 BACKGROUND

• 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.

  PMID: 33619855 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Brett Miles
• Organization: Icahn School of Medicine at Mount Sinai

brett.miles@mountsinai.org

(212) 241-9410

Study Officials

• Eric Genden, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Brett Miles, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: September 13, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)