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Minimum Local Anesthetic Dose for Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT03427385
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The purpose of this study is to determine the minimum dose of ropivacaine 0.5%, required to produce pain relief without weakening the leg muscles.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Ropivacaine 0.5% Not Applicable

Detailed Description:

The post-operative period after a Total Knee Arthroplasty (TKA) is known to be especially painful for the first 24 hours. Significant pain can persist up to 3 days in some cases. Successful management of pain post TKA is therefore regarded as essential to early recovery, rehabilitation and timely discharge.

Until now, multiple modes of analgesia have been employed including intravenous patient-controlled analgesia, continuous femoral nerve block and epidural analgesia. These are all effective alternatives but each is limited by side effects. Epidural analgesia provides excellent pain control and has been associated with early rehabilitation despite its negative impact on ambulation in the immediate peri-operative period. Additionally, an increased risk of spinal hematoma has been reported with epidural analgesia and peri-operative low molecular weight heparin prophylaxis. For this reason, epidural analgesia is not routinely offered to patients undergoing TKA today.

A multimodal analgesic approach centered on the use of continuous femoral nerve blocks has been more recently favoured, providing superior analgesia and less opioid-related side effects than a systemic opioid-based regimen. However, femoral nerve blockade is also associated with significant quadriceps muscle weakness, which can impair ambulation, delay physiotherapy and result in accidental fall.

Recent reports suggest that saphenous nerve blockade using an adductor canal approach is a novel technique with which to provide adequate analgesia for major knee surgery. Ultrasound-guided saphenous nerve block in the adductor canal is considered a technically simple and reliable block, providing consistent success. Although traditionally used to provide anesthesia and analgesia to the foot and ankle, recent reports suggest that saphenous nerve blockade in the adductor canal may provide adequate analgesia for major knee surgery. Taking into consideration the anatomy of the adductor canal, it appears possible to target not only the saphenous nerve but also multiple branches of the femoral and obturator nerve.

However, the optimal dose of local anesthetic required to establish knee analgesia without inducing quadriceps weakness has not yet been determined. Identifying an optimal dose would allow for maximum analgesic efficacy with minimal or no motor block, while minimizing other unwanted adverse effects.

This pilot study is designed to determine the optimal dose of ropivacaine 0.5% required to initiate sensory knee analgesia for the post-operative.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Minimum Effective Local Anesthetic Dose for Adductor Canal Block for Knee Analgesia − a Preliminary Study
Actual Study Start Date : September 2012
Actual Primary Completion Date : August 5, 2014
Actual Study Completion Date : August 5, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Minimum Effective dose
Local anesthetic Ropivacaine 0.5% injection for adductor canal block
Drug: Ropivacaine 0.5%
The volume of local anesthetic Ropivacaine 0.5% will be determined by the response (success or failure of block, 30 minutes after local anesthetic injection) of the previous patient in that group. Block success is defined as an absence of ice sensation in the knee within 30 min of ropivacaine administration accompanied by tolerance to tetanic electrical stimulation (TES) at 60 mA(milliamp) for 5 seconds.
Other Name: Naropin




Primary Outcome Measures :
  1. Tolerance to Transcutaneous Electrical Stimulation (TES) [ Time Frame: 30 min after ropivacaine injection ]
    To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.


Secondary Outcome Measures :
  1. The degree of motor block following ropivacaine administration [ Time Frame: Assessments will start at baseline before ropivacaine injection and every 5 minutes after ropivacaine injection until 45 minutes have passed or until surgery commences, whichever comes first ]
    Motor block will be assessed using an isometric force dynamometer

  2. Cold sensation [ Time Frame: 30 min after ropivacaine injection ]
    To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.


Other Outcome Measures:
  1. Total opioid consumption [ Time Frame: 48 hours ]
    Total opioid consumption during the intraoperative phase, post-operative care unit stay, and during the first 48 hours post-surgery



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA(American Society of Anesthesiologists)physical status classification system I-III
  • 18-85 years of age, inclusive
  • BMI 18 - 40
  • Scheduled for elective total knee replacement under spinal anesthesia or general anesthesia.

Exclusion Criteria:

  • Inability or refusal to provide informed consent
  • Any contraindication to regional anesthesia (allergy to local anesthetics, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427385


Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Vincent WS Chan, MD University Health Network, Toronto
Study Chair: Richard Brull, MD University Health Network, Toronto
Study Chair: Ki Jinn Chin, MD University Health Network, Toronto
Study Chair: Anahi Perlas, MD University Health Network, Toronto

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03427385     History of Changes
Other Study ID Numbers: 11-0635-A
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by University Health Network, Toronto:
Neuromuscular blockade

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents