PIB Versus CI Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle Surgery

Pain, Postoperative Clinical Trial

Official title: Comparing the Delivery of Local Anesthetic by Programmed Intermittent Bolus Versus Continuous Infusion Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle Surgery

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

Peripheral nerve blocks are commonly used for upper and lower limb surgery. Continuous popliteal sciatic nerve block achieved by delivery of local anesthetic through a perineural catheter plays an important role in post-operative pain control after major orthopedic surgeries of the ankle and foot. Factors affecting the success and clinical outcome of continuous sciatic nerve blocks include the accuracy of catheter placement, the local anesthetic dose (volume and concentration), and the infusion method.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

• NCT number: NCT02707874
• Study type: Interventional
• Source: University Health Network, Toronto
• Contact: Rongyu Jin, MD
• Phone: 416-603-5800
• Email: rongyu.jin@uhn.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2014
• Completion date: June 2018