Arthrosis, Unspecified, Ankle and Foot Clinical Trial
— PEUSBOfficial title:
Comparison of the Effect of a Single Shot Saphenous Block With Plain Bupivacaine vs. Protracted Bupivacaine Mixture as a Supplement to Continuous Sciatic Catheter After Major Ankle and Foot Surgery
This study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. The hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | February 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis - Age = 18 - American Society of Anaesthesiology Classification I-III - Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. Exclusion Criteria: - Communication problems or dementia - Allergies to any medical product used in the study - Neuropathy of the sciatic or femoral nerve prior to the operation - Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease - BMI > 35 - Pregnancy - Daily use of opioids - Coagulation disorders - Infection at the site of injection or systemic infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Anesthesiology, Aarhus University Hospital | Aarhus | Midtjylland |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus |
Denmark,
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* Note: There are 30 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of the saphenous nerve block | The duration is registered as the time until the first dose of morphine is taken, and when the pain score is above 3 and located to the frontal or medial side of the ankle. Morphine is administered intravenously by a patient controlled pump (PCA - Patient Controlled Analgesia) | 48 hours | No |
| Secondary | Cumulated opioid consumption | Registered by the PCA pump | 48 hours | No |
| Secondary | Pain score | NRS (numeric rating scale) | Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery | No |
| Secondary | Pain localization | Lateral or medial side of the ankle | Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery | No |
| Secondary | Test of sensory block | The sensory block of the peroneal nerve is tested on the dorsal side of the toes and the tibial nerve on the plantar side of the toes. The ankle and lower leg is covered in cast, and therefore the saphenous nerve is tested around the tibial tuberosity because this area is innervated by the infra-patellar nerve, which is a branch of the saphenous nerve |
Arrival at the Perioperative Section which will be within 30 minutes after surgery. Departure from the Perioperative Section which is expected to be on average 2 hours after surgery. 6, 12, 24, 30, 36, 42 and 48 hours after surgery | No |