About this trial
Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score.
This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective orthopaedic surgery on the upper limb
Patients scheduled for elective orthopaedic surgery on the lower limb.
Score ASA I-III; Patients aged over 18 years; Signed informed consent.
Surgery under general anaesthesia or under sedation
Disqualifiers
Refusal or inability to understand the informed consent
Allergy to any of the following medications: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine,sufentanil, ondansetron, or dexamethasone
Patients with long term opioid treatment
Bleeding diathesis
Trial design
Parallel
Treatments tested in this trial
Morphine provided via oral PCA
DrugMorphine will be administered according to a scheduled regimen (20mg slow release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.
Morphine provided via oral PCA + morphine administered at a scheduled regimen
Drugmorphine will be administered according to a scheduled regimen (20mg slow-release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.
Treatment groups
Trial outcomes
Primary outcomes
Worst pain score during the first 24 hours after surgery
Highest postoperative pain score during the first 24 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Secondary outcomes
Minimal pain score during the first 12 hours after surgery
Lowest postoperative pain score during the first 12 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Rebound pain score measured using the Visual Analog Scale (VAS)
Rebound pain score calculated as the difference between the highest postoperative pain score within the first 24 hours after surgery and the lowest postoperative pain score within the first 12 hours after surgery. Pain intensity is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher rebound pain scores indicate greater pain rebound
Rest and dynamic pain scores
Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Score (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Incidence of severe pain
Pain evaluated at \>7/10, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Sponsors and contacts
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