A Phase 4 interventional study of Ropivacaine 0.2% in Postoperative Pain, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by Nordsjaellands Hospital · Phase 4, Interventional, and Treatment
BACKGROUND
Orthopedic surgery can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Furthermore, in catheter-based techniques, whether a low-dose automated, periodic infusion can produce similar analgesic effectiveness compared to a conventional, high dose, continuous infusion has never been explored.
AIM
Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a conventional continuous infusion and patient-controlled boluses only in catheter-based nerve blocks for patients undergoing orthopedic surgery to the foot or ankle.
BACKGROUND
Orthopedic surgery has been reported to be moderate to severely painful in approximately 50 % of patients.
Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly recommended as part of a multimodal, perioperative, analgesic treatment. Patients who are expected to have postoperative, severe pain exceeding the duration of a single injection nerve block may benefit from a catheter-based nerve block (CBNB) using either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA). Intermittent boluses can be either patient-controlled or prescribed in combination with a continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is superior to a single injection nerve block after orthopedic surgery remains unanswered.
There are several challenges when using a CBNB treatment: The dosing or delivery method may be either insufficient and thus not pain relieving or too powerful resulting in dense motor block and limb anesthesia which may compromise safety and rehabilitation. The peripheral nerve block catheter may also displace and therefore deposit LA too far from the targeted nerve(s) to produce an effective nerve block.
Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI. It seems that an API produces better pain control, a lower analgesic consumption over time and less motor inhibition. This is well-described for epidural catheters for laboring women, but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve block treatment may even out the difference in pain scores between API and CI. However, it seems that API groups require less LA via PCA function. Reducing LA consumption is of great importance for ambulatory patients whose LA reservoir is limited, but also for all other orthopedic patients whose motor block should be minimized in order to optimize rehabilitation.
OBJECTIVES
To investigate whether a low-dose API with patient-controlled bolus option can produce a similar analgesic effect compared to a conventional, high dose, CI with patient-controlled bolus option in catheter-based peripheral nerve blocks for patients undergoing orthopedic surgery to the foot or ankle. Analgesic effectiveness will be compared with a group only given the patient-controlled bolus option.
HYPOTHESIS
Low dose API with supplemental patient-controlled bolus option will provide pain-relieving therapy not inferior to a conventional CI with supplemental patient-controlled bolus option. The intervention group receiving patient-controlled boluses only will experience more pain breakthrough.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 85 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infusion of ropivacaine 0.2 %, 10 mL, every 8th hour. Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
Drug: Ropivacaine 0.2%
Continuous infusion of ropivacaine 0.2 %, 6 mL/hour. Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
Drug: Ropivacaine 0.2%
Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
Drug: Ropivacaine 0.2%
Perineural infusion of Ropivacaine 0.2% using a peripheral nerve block catheter and a portable infusion pump.
Also known as: Naropin 0.2%
Postoperative pain, 1-72 hours postoperatively
Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.
Time frame: 1-72 hours
Opioid consumption, 1-72 hours postoperatively
Tablets consumed during the period of investigation
Time frame: 1-72 hours
Volume of patient-initiated boluses, 1-72 hours postoperatively
Volume of ropivacaine 0.2 % (mL) used for patient-initiated boluses, 1-72 hours postoperatively
Time frame: 1-72 hours
Opioid related side effects
Patient reported symptoms: dizziness, nausea, itching, constipation
Time frame: 1-72 hours
Pain at bolus request
Pain (VAS, 0-100 milimetres) at the time of patient-initiated bolus
Time frame: 1-72 hours
Motor nerve block
Degree of motor nerve block, defined by paresis or paralysis in the ankle dorsi- and plantarflexion movement.
Time frame: 1-72 hours
Sensory nerve block
Insensitivity towards cold in the lateral aspects of the lower leg and beneath the foot. This will be recorded by the patient using a cold glass vial stored in a refrigerator until its use.
Time frame: 1-72 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Feb 2019, 14 months.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 14 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Nordsjaellands Hospital