Continuous Adductor Canal Nerve Blocks: Relative Effects of a Basal Infusion v. Hourly Bolus Doses

NCT02219438 | Completed Phase 4 Results

• 1 other identifier: Adductor Canal Basal vs Bolus
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Patients usually experience moderate-to-severe pain following the knee replacement that is often treated with a femoral nerve block (injection of numbing medicine placed around the main nerve of the knee joint). To make the nerve block last longer, a tiny tube is often placed next to the nerve and numbing medicine is infused for multiple days. However, while the numbing medicine takes away pain, it also decreases sensations, muscle strength, and proprioception (knowing where the leg is in space without looking at it) which greatly increases the risk of falling. Since falling can be catastrophic following major surgery, a femoral nerve blocks are being phased out by surgeons and anesthesiologists. The most-promising replacement is called an adductor canal nerve block. For this new type of block, a perineural catheter is inserted into a small canal in the middle of the upper leg. This canal contains the sensory nerve fibers leading to the knee, and only a single nerve that serves a relatively small muscle. Multiple studies have demonstrated a dramatic increase in muscle strength using the new adductor canal block compared with the traditional femoral block. However, practitioners perceptions of the new block is that it provides insufficient pain control following knee arthroplasty, even though all of the sensory nerves affected with the femoral block are also-theoretically-affected with the adductor canal block. One reason for this difference may be the small canal of the latter which is a relatively tight area in which the numbing medicine might not spread particularly well (due to pressure from surrounding tissues). One way to possibly counter this issue is by providing repeated boluses of the numbing medicine that will improve the medicine's spread relative to a more-traditional slow, continuous ("basal") infusion. This study seeks to compare these two techniques of medication administration through perineural adductor canal catheters: Our primary aim is to test the hypothesis that, for continuous adductor canal blocks, providing local anesthetic as repeated, hourly bolus doses results in an increased sensory block compared with providing local anesthetic as a continuous basal infusion at an equivalent hourly dose. As a secondary aim, we hypothesize that, for continuous adductor canal blocks, providing local anesthetic as repeated, hourly bolus doses results in either equivalent or less motor block compared with providing local anesthetic as a continuous basal infusion at an equivalent hourly dose.

Conditions

Healthy Human Volunteers

Outcome Measures

Primary Outcomes (1)

• Tolerance to Cutaneous Electrical Current

  Evaluated in the seated position using transcutaneous electrical stimulation (TES) in the same manner as described throughout the anesthesia literature (this is a "gold standard" for regional anesthesia studies). EKG pads will be positioned over the proximal patella and quadriceps tendon 1 cm medial of midline and attached to a nerve stimulator. The current will be increased from 0 mA until the subject reports slight discomfort (or, up to a maximum of 80 mA), at which time the current is recorded as the TES value and the nerve stimulator turned off.

  After 8 h of infusion

Secondary Outcomes (2)

• Tolerance to Transcutaneous Electrical Current

  baseline through Hour 14 (except Hour 8 which is the primary outcome) and then again at Hour 22

• Maximum Voluntary Isometric Contraction of the Quadriceps

  Baseline and then every hour through Hour 14, as well as Hour 22

Study Arms (2)

RIGHT side BOLUS and left side basal

EXPERIMENTAL

Bilateral adductor canal catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as hourly bolus doses of 8 mL each a total of 8 times: one at time point zero and 1 on the hour for the following 7 hours. For the left catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 8 hours

Drug: Bolus; Drug: Basal

RIGHT side BASAL and left side bolus

ACTIVE COMPARATOR

Bilateral adductor canal catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 8 hours. For the left catheter, the ropivacaine was administered as hourly bolus doses of 8 mL each a total of 8 times: one at time point zero and 1 on the hour for the following 7 hours.

Drug: Bolus; Drug: Basal

Interventions

Bolus DRUG

An adductor canal catheter was inserted and ropivacaine 0.2% administered as hourly bolus doses of 8 mL each: one at time point zero and then on the hour for 7 additional doses.

Also known as: hourly bolus doses

RIGHT side BASAL and left side bolus; RIGHT side BOLUS and left side basal

Basal DRUG

An adductor canal catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for a total of 8 hours.

Also known as: continuous basal infusion

RIGHT side BASAL and left side bolus; RIGHT side BOLUS and left side basal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age ≥ 18 years; and (2) willing to have bilateral adductor canal perineural catheters placed with subsequent ropivacaine administration and motor/sensory testing for 14 hours, requiring an overnight stay in the UCSD CTRI-CCR to allow dissipation of local anesthetic infusion effects by the following morning.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92103, United States

Location

Related Publications (1)

• Monahan AM, Sztain JF, Khatibi B, Furnish TJ, Jaeger P, Sessler DI, Mascha EJ, You J, Wen CH, Nakanote KA, Ilfeld BM. Continuous Adductor Canal Blocks: Does Varying Local Anesthetic Delivery Method (Automatic Repeated Bolus Doses Versus Continuous Basal Infusion) Influence Cutaneous Analgesia and Quadriceps Femoris Strength? A Randomized, Double-Masked, Controlled, Split-Body Volunteer Study. Anesth Analg. 2016 May;122(5):1681-8. doi: 10.1213/ANE.0000000000001182.

  PMID: 26863502 RESULT

MeSH Terms

Interventions

NOP-bolus regimen

Results Point of Contact

• Title: Dr Brian Ilfeld
• Organization: UCSD

bilfeld@ucsd.edu

(619) 543-5560

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only individual aware of the treatment group assignments is the investigational pharmacist who has no interaction with the study subjects. Treatment group assignments were released by the investigational pharmacy only after completion of data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: This is a split-body study in which each study subject receives both treatments: one on each side of the body. Which treatment is applied to which side of the body is randomized (and masked).

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 19, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)