Post Operative Analgesia, Post Operative Pain, Acute, Rebound Pain
Conditions
Keywords
rebound pain, postoperative pain, pain management, orthopaedic surgery, peripheral nerve block
Brief summary
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.
Detailed description
This study contains two parts, one for the upper limb and one for the lower limb. Each part will be published independently. This registration concerns the upper limb cohort. Patients from each cohort (upper limb and lower limb) will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients per cohort. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list. In the control group, morphine will be administered exclusively on demand via oral PCA,based on pain intensity assessed using a numeric rating scale (VAS \> 4). For oral PCA, one10 mg morphine tablet is placed on the patient's bedside table by the nursing staff. When the patients experience pain, they may take the tablet autonomously and subsequently inform the nurse, who then prepares and places a new tablet at bedside for the next potential pain episode. No scheduled or prophylactic opioid administration will be provided in this group. The maximal allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period. In the intervention group, morphine will be administered at predefined regular intervals, starting immediately in the postoperative period in addition to the availability of oral PCA morphine as mentioned above. Scheduled doses of 20mg slow-release oral morphine will be given at fixed 12 hour intervals. Patients will therefore receive regular morphine to ensure continuous baseline analgesia while still having access to an additional tablet via oral PCA in case of breakthrough pain, following the same nursing procedure as in the control group. In both groups, standardized multimodal analgesia will be provided The primary objective of this study is to assess and compare the highest pain score within the first 24 postoperative hours between the two groups using the Visual Analog Scale (VAS). The secondary objective is to assess the effect of the intervention on postoperative pain and analgesic outcomes, including morphine consumption, pain scores, need for additional nerve blocks, incidence of chronic pain, duration of analgesia, postoperative side effects, complications, and hospital length of stay.
Interventions
Morphine 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 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.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Neurological disorders of the operated limb * Known renal insufficiency (eGFR \<30 mL/min) * Known hepatic insufficiency (Child-Pugh class B or C); * Pregnant or breastfeeding women; * Alcohol dependence syndrome; * Patients under spinal anaesthesia; * Patients undergoing amputation procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst pain score during the first 24 hours after surgery | 24 hours postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Minimal pain score during the first 12 hours after surgery | 12 hours postoperatively | 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) | From surgery until 24 hours postoperatively | 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 | At 2, 12, 24, 36, 48, 60, and 72 hours after surgery | Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Incidence of severe pain | From surgery through 3 months after surgery | Pain evaluated at \>7/10 (VAS), measured using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Persistence of pain | During the follow-up period from discharge till 4 weeks and 3 months | Incidence of persistent pain at 4 weeks and chronic pain at 3 months |
| Morphine consumption in the recovery room | from admission until discharge from the recovery room, up to 2 hours | consumption in mg |
| PCA administered morphine consumption at day 1, 2 and 3 | Day 1, 2 and 3 postoperatively | Consumption in mg administered by PCA |
| Total administered morphine consumption at day 1, 2, and 3 | Day 1, 2 and 3 postoperatively | Total consumption in mg |
| Incidence of postoperative nausea and vomiting | At 2 hours, day 1, day 2 and day 3 postoperatively | Presence of nausea or vomiting in the postoperative period |
| Incidence of pruritus | At 2 hours, day 1, day 2 and day 3 postoperatively | Presence of pruritus in the postoperative period |
| Incidence of urinary retention requiring bladder catheterisation | At 2 hours, day 1, day 2 and day 3 postoperatively | Urinary retention requiring catheterisation |
| Hospital length of stay | At the time of hospital discharge (typically within 5 days, according to our hospital standard practice) | Duration of hospitalization, measured as the number of days from surgery to hospital discharge. Higher values indicate longer hospital stays. |
| Requirement for a new peripheral nerve block | On postoperative day 1, 2 and 3 | Requirement for a new peripheral nerve block |
| Duration of analgesia | From the time the block is performed up to 36 hours after surgery | Time between block performance and the first dose of morphine |
Countries
Switzerland
Contacts
CONTACTEric Albrecht, Prof.
CONTACTIliana Mrazek
Outcome results
None listed