Recruiting

PIB vs. CI

Sponsor:

University Health Network, Toronto

Code:

NCT02707874

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CI 0.2% ropivacaine

PIB 0.2% ropivacaine

Study Details

Brief summary:

This is a clinical study to investigate and compare a new programmed intermittent bolus (PIB) delivery method for continuous popliteal sciatic nerve block for pain relief in patients undergoing major ankle surgery compared with the current practice of continuous local anesthetic infusion (CI).

Conditions

Pain, Postoperative

Study ID

NCT02707874

Start date

Oct, 2014

Status verified date

Oct, 2016

Completion date

Jun, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inpatients having major foot and ankle surgery that will benefit from continuous popliteal sciatic nerve block with an indwelling catheter
  • 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:

  • Patients who undergo iliac crest bone graft harvesting as part of their surgery
  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Average numerical rating score (NRS) for pain [ Time Frame: post-operative 48 hours ]

Central Contacts and Locations

Central contacts

Rongyu Jin, MD

416-603-5800rongyu.jin@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 31, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2016-10-31.