PIB Versus CI Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle Surgery
NCT ID: NCT02707874
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2014-10-31
2018-06-30
Brief Summary
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Detailed Description
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Methods of local anesthetic infusion commonly used for peripheral nerve blockade include continuous infusion (CI) and CI combined with patient-controlled analgesic (PCA) boluses. A third option, regular intermittent boluses of local anesthetic, is not commonly used as it usually requires manual administration by a healthcare provider and is thus time and labor-intensive. Recently, however, infusion pumps capable of providing automated programmed intermittent bolus (PIB) dosing have become available.
The premise of PIB dosing is that it results in more extensive spread of local anesthetic around nerves, and thus more effective sensory block and analgesia. PIB dosing regimens have been extensively studied in labor epidural analgesia, where they have been shown to decrease local anesthetic consumption and improve maternal satisfaction when compared with continuous infusion regimens.
In contrast, there has been little investigation into PIB dosing regimens in the context of continuous peripheral nerve blockade. In 2005, Taboada et al 2 published a study that compared automated PIB dosing with CI dosing of local anesthetic for continuous popliteal sciatic nerve blockade. In both regimens, patients were also allowed to administer PCA boluses of local anesthetic as needed to improve the quality of the nerve block. The authors found that the automated PIB dosing regimen resulted in patients using less local anesthetic and fewer PCA boluses, while providing equivalent analgesia. There was a non-significant trend to lower pain scores in the PIB group of patients. These effects are attributed to better perineural spread of local anesthetic with the PIB regimen. No other studies have been conducted to confirm these benefits.
The reduced local anesthetic requirement is of particular advantage in patients who are discharged home with a nerve block catheter in situ as the supplied reservoir of local anesthetic will last longer. Ambulatory infusion pumps with both PIB and PCA features are now commercially available. The investigators hypothesize that a PIB+PCA dosing regimen using one of these new ambulatory infusion pumps will provide more effective postoperative analgesia with less local anesthetic consumption than the CI+PCA dosing regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CI 0.2% ropivacaine
Patients in Group Continuous Infusion (CI) will receive continuous infusion of 0.2% ropivacaine at 5 mL/hour; total 4-hourly consumption = 20 mL = 40 mg ropivacaine.
• All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required.
2\) Oral patient controlled analgesia (PCA) using oxycodone or hydromorphone. Patients under 70 years of age will receive either 10 mg of oxycodone or 2 mg of hydromorphone 2 hourly as needed, and patients 70 years of age or older will receive 5 mg of oxycodone or 1 mg of hydromorphone 2 hourly as needed.
3\) Oral acetaminophen 1,000 mg 6 hourly.
CI 0.2% ropivacaine
Patients in Group CI will receive continuous infusion of 0.2% ropivacaine at 5 mL/hour; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
PIB 0.2% ropivacaine
Patients in Group programmed intermittent boluses (PIB) will receive automated programmed intermittent boluses of 10 mL of ropivacaine 0.2% every 2 hours; total 4-hourly consumption = 20 mL = 40 mg ropivacaine.
• All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required.
2\) Oral patient controlled analgesia (PCA) using oxycodone or hydromorphone. Patients under 70 years of age will receive either 10 mg of oxycodone or 2 mg of hydromorphone 2 hourly as needed, and patients 70 years of age or older will receive 5 mg of oxycodone or 1 mg of hydromorphone 2 hourly as needed.
3\) Oral acetaminophen 1,000 mg 6 hourly.
PIB 0.2% ropivacaine
Patients in Group Programmed intermittent bolus (PIB) will receive automated programmed intermittent boluses of 10 mL of ropivacaine 0.2% every 2 hours; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
Interventions
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CI 0.2% ropivacaine
Patients in Group CI will receive continuous infusion of 0.2% ropivacaine at 5 mL/hour; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
PIB 0.2% ropivacaine
Patients in Group Programmed intermittent bolus (PIB) will receive automated programmed intermittent boluses of 10 mL of ropivacaine 0.2% every 2 hours; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society Anesthesiologists (ASA) physical status I-III
* 18-85 years of age, inclusive
* 40-120 kg, inclusive
* 150 cm of height or greater
Exclusion Criteria
* Preexisting neurological deficits or peripheral neuropathy in the distribution of the sciatic nerve
* Local infection
* Contraindication to regional anesthesia e.g. bleeding diathesis, coagulopathy
* Chronic pain disorders
* History of use of over 30mg oxycodone or equivalent per day
* Allergy to local anesthetics
* History of significant psychiatric conditions that may affect patient assessment
* Pregnancy
* Inability to provide informed consent
18 Years
85 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Ki Jinn Chin, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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References
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George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
Taboada M, Rodriguez J, Bermudez M, Amor M, Ulloa B, Aneiros F, Sebate S, Cortes J, Alvarez J, Atanassoff PG. Comparison of continuous infusion versus automated bolus for postoperative patient-controlled analgesia with popliteal sciatic nerve catheters. Anesthesiology. 2009 Jan;110(1):150-4. doi: 10.1097/ALN.0b013e318191693a.
Chludzinski A, Irani C, Mascha EJ, Kurz A, Devereaux PJ, Sessler DI. Protocol understanding and anxiety in perioperative clinical trial patients approached for consent on the day of surgery. Mayo Clin Proc. 2013 May;88(5):446-54. doi: 10.1016/j.mayocp.2012.12.014.
Short AJ, Ghosh M, Jin R, Chan VWS, Chin KJ. Intermittent bolus versus continuous infusion popliteal sciatic nerve block following major foot and ankle surgery: a prospective randomized comparison. Reg Anesth Pain Med. 2019 Sep 29:rapm-2018-100301. doi: 10.1136/rapm-2018-100301. Online ahead of print.
Other Identifiers
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REB#13-6466
Identifier Type: -
Identifier Source: org_study_id