- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03607227
Continous Popliteal Block for Microvascular Free Flap Reconstruction in Ear, Nose and Throat Surgery
Does Continuous Popliteal Nerve Block Improve Pain Management for Patients Undergoing Major Maxilla or Mandible Resection With Microvascular Reconstruction Using a Free Fibula Graft
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tumors of the head and neck is one of the most common cancer types, and the incidence is increasing. Management of these tumors is complex, and treatment can include surgery with extensive resection of the mandible or maxilla, which requires reconstruction using a microvascular free flap, oftentimes a part of the fibula. The injury to the operated leg can cause significant postoperative pain, which in these patients traditionally has been treated with intravenous opioids. These drugs have good analgesic properties, but also several side effects, such as fatigue, nausea and respiratory depression. The experience at Skåne University hospital in Lund has also been that the analgesic effect in the leg has been insufficient. The investigators would therefore like to evaluate the effect of adding a continuous popliteal block on postoperative pain and opioid consumption, as well as postoperative recovery. This type of block is regularly used for orthopedic surgery of the fibula, but its effects and significance have not been evaluated for the patient group in question.
Patients will receive information about the study and, if they opt to participate, be included during the routine preoperative visit. All patients included in the study will preoperatively receive a popliteal nerve block catheter in technical accordance with local procedure guidelines, and be randomized to either active substance (local anesthetic) or placebo (saline solution). They will receive a bolus injection of the allotted substance (blinded to both patient, care provider and investigator) at the start of surgery, followed by continuous infusion during the first, maximally, seven days. During this period pain, nausea and vomiting, as well as sensory and motor function in the operated leg will be recorded regularly. Opioid consumption, need for other analgesics and ability to mobilize will also be noted. Follow up of above mentioned parameters will be made at the first routine office visit at three months postoperatively.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Skane
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Lund, Skane, Sweden, 22185
- Skane University Hospital Lund, Divison of Anaestesia and Intensive Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients at Skåne University hospital department of ear, nose and throat surgery undergoing major resection of maxilla or mandible and reconstruction using free fibula graft.
- Preoperatively able to walk (with or without aid).
Exclusion Criteria:
- Neurological disease or peripheral neuropathy affecting the donor leg of the fibula graft.
- Conditions of coagulopathy, or treatment with anticoagulant drugs, that contraindicates peripheral nerve block according to local guidelines.
- Local anesthetic allergy.
- Inability to understand study information or answer questions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Local anesthetic
Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.
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Active substance.
Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.
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Placebo Comparator: Saline
Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as in the active substance arm.
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Placebo.
Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as the active substances.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain assessed by VAS (ranging from 0 (no pain) to 10 (worst possible pain)).
Time Frame: Assessment of pain using VAS three times a day during the first seven postoperative days, with follow-up at the first office visit three months after surgery.
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Change in pain in the operated leg, measured with visual analogue scale (VAS), between the two study groups (the two study arms described above).
VAS assesses self-perceived pain.
The scale ranges from 0 (meaning no pain at all) to 10 (meaning worst possible pain).
Low VAS scores (representing no to low pain) are better than high VAS scores (representing severe pain).
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Assessment of pain using VAS three times a day during the first seven postoperative days, with follow-up at the first office visit three months after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative nausea, assessed by VAS (ranging from 0 (no nausea) to 10 (worst possible nausea)), and vomiting (yes/no).
Time Frame: Assessment of nausea using VAS and occurence of vomiting (yes/no) three times a day during the first seven postoperative days, with follow-up assessment of nausea at the first office visit three months after surgery.
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Change in nausea, measured with visual analogue scale (VAS), and occurence of vomiting (yes/no), between the two study groups (the two study arms described above).
VAS assesses self-perceived nausea.
The scale ranges from 0 (meaning no nausea at all) to 10 (meaning worst possible nausea).
Low VAS scores (representing none to little nausea) are better than high VAS scores (representing severe nausea).
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Assessment of nausea using VAS and occurence of vomiting (yes/no) three times a day during the first seven postoperative days, with follow-up assessment of nausea at the first office visit three months after surgery.
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Postoperative sensory and motor function in the operated leg assessed by a simplified scale (ranging from 0 to 2, see description below).
Time Frame: Assessment of sensory and motor function using the scale described above three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Change in sensory and motor function in the operated leg between the two study groups (the two study arms described above) is assessed using a local simplified scale.
The intervals are 0 (meaning no impact on sensory/motor function), 1 (meaning some impact on sensory/motor function) and 2 meaning severe impact on sensory/motor) function.
Sensory function is self-perceived during touching of the forefoot, while motor function (tested as flexion of the ankle and toes) is evaluated by the investigator.
Low scores (representing no or little impact on sensory/motor function) are better than high scores (indicating more impact on sensory/motor function).
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Assessment of sensory and motor function using the scale described above three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Ability of postoperative mobilization (sitting/standing/walking, with or without tools/aids).
Time Frame: Assessment of level of mobilization (sitting/standing/walking) three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Ability of/level of postoperative mobilization (sitting/standing/walking).
Tools/aids (walker/cain/staff members) needed are reported (if any).
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Assessment of level of mobilization (sitting/standing/walking) three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Opioid consumption in the postoperative period.
Time Frame: Notation of the amount of opioids (preparation, route and dose) consumed is noted daily during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Amount of opioids needed in the postoperative period.
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Notation of the amount of opioids (preparation, route and dose) consumed is noted daily during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louise Walther Sturesson, MD, PhD, Skåne University Hospital, Region Skåne
Publications and helpful links
General Publications
- Marur S, Forastiere AA. Head and Neck Squamous Cell Carcinoma: Update on Epidemiology, Diagnosis, and Treatment. Mayo Clin Proc. 2016 Mar;91(3):386-96. doi: 10.1016/j.mayocp.2015.12.017.
- Ragbir M, Brown JS, Mehanna H. Reconstructive considerations in head and neck surgical oncology: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S191-S197. doi: 10.1017/S0022215116000621.
- Dort JC, Farwell DG, Findlay M, Huber GF, Kerr P, Shea-Budgell MA, Simon C, Uppington J, Zygun D, Ljungqvist O, Harris J. Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):292-303. doi: 10.1001/jamaoto.2016.2981.
- Borgeat A, Blumenthal S, Lambert M, Theodorou P, Vienne P. The feasibility and complications of the continuous popliteal nerve block: a 1001-case survey. Anesth Analg. 2006 Jul;103(1):229-33, table of contents. doi: 10.1213/01.ane.0000221462.87951.8d.
- White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Head and Neck Neoplasms
- Musculoskeletal Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Levobupivacaine
Other Study ID Numbers
- Region Skane 20180602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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