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A Comparison Between a PC and a CC Approach for the Placement of Infraclavicular Perineural Catheters in Hand Surgery

Primary Purpose

Postoperative Pain, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Placement of an infraclavicular perineural catheter using a costoclavicular approach
Placement of an infraclavicular perineural catheter by paracoracoid approach
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Infraclavicular perineural catheters, Hand surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years old
  • American Society of Anesthesiologists' classification 1 to 3
  • Patients undergoing elective ambulatory hand surgery requiring the use of continuous infraclavicular nerve block

Exclusion Criteria:

  • Contraindication to a peripheral nerve block
  • Refusal of the patient or inability to consent
  • Inability to communicate with the healthcare team or the research team
  • Lack of access to the Teams telehealth platform
  • Inability to understand the items of the different questionnaires
  • Inability to understand ambulatory catheter follow-up instructions
  • Pregnancy
  • Obesity Body Mass Index > 40
  • Pre-existing neurological deficit in the operated upper limb
  • Anatomical malformation not allowing one of the study blocks to be performed
  • Condition preventing measurement of the primary outcome

Sites / Locations

  • Centre hospitalier de l'Université de Montréal (CHUM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Infraclavicular nerve block using a costoclavicular approach

Infraclavicular nerve block using a paracoracoid approach

Arm Description

The costoclavicular approach, more recently described, proposes an insertion of the needle under the lower edge of the clavicle but in a lateral way to the axillary artery which makes it possible to reach the nerves at a place where the 3 main nerve bundles are still joined together. The clustering of nerve structures at the injection site may facilitate the spread of local anesthetics.

The paracoracoid approach involves inserting a needle under the lower rim of the clavicle below the coracoid process. This approach makes it possible to reach the 3 different nerve bundles, located around the axillary artery, which are involved in the sensitivity of the hand.

Outcomes

Primary Outcome Measures

Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).

Secondary Outcome Measures

Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm
Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm (ulnar, median, radial, musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned according to the motor response (0 = Normal force compared to the contralateral side, 1 = Decrease in force (possible movement against gravity) compared to the contralateral side, 2 = no movement possible)
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).
Time to complete catheter placement
The time needed to complete catheter placement by the anesthesiologist in seconds
Occurrence of adverse events during the block
The adverse events occurring during the block will be noted, such as vascular punctures, pneumothorax, paresthesias, repositioning for failure to raise the catheter through the needle.
Rate of complete sensory block
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al., 30 minutes after the catheter placement. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).
Rate of complete motor block
Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm (ulnar, median, radial, musculocutaneous) using the score described by Boivin et al., 30 minutes after the catheter placement. A score of 0 to 2 will be assigned according to the motor response (0 = Normal force compared to the contralateral side, 1 = Decrease in force (possible movement against gravity) compared to the contralateral side, 2 = no movement possible)
Worst pain during the block technique
Worst pain during the block technique assessed using a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Total opioid consumption
Time between the end of surgery and the first opioid dose
Minimum pain after the surgery
Minimum pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Maximum pain after the surgery
Maximum pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Average pain after the surgery
Average pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Percentage of time spent with moderate to severe pain
Percentage of time spent with moderate to severe pain (> 4/10) using a numerical scale where 0 = no pain and 10 = worst pain imaginable
Rate of complications or adverse effects
The rate of complications or adverse effects during the first 48 hours will be assessed, such as local anesthetic toxicity, nausea, vomiting, dizziness, drowsiness and accidental withdrawal of the catheter.
Quality of sleep
The quality of sleep of the patient will be evaluated, rated on a scale where 0 = insomnia and 10 = excellent quality sleep.
Patient's satisfaction
The satisfaction of the patient will be evaluated, rated on a scale where 0 = completely dissatisfied and 10 = fully satisfied.

Full Information

First Posted
July 2, 2021
Last Updated
August 2, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04960046
Brief Title
A Comparison Between a PC and a CC Approach for the Placement of Infraclavicular Perineural Catheters in Hand Surgery
Official Title
A Comparison Between a Paracoracoid Approach and a Costoclavicular Approach for the Placement of Infraclavicular Perineural Catheters in Hand Surgery: a Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In outpatient hand surgery, 40% of patients report moderate to severe pain within 24 hours of the operation. Effective pain management is therefore essential to ensure a comfortable and safe return home for the patient. Loco-regional anesthesia is the optimal method of analgesia for complex hand surgery. It involves the injection of a local anesthetic (LA) near the nerves responsible for the sensitivity of the arm. Following a single injection of long-acting local anesthetic, the maximum duration of analgesia is limited to approximately 13 hours, with great variability between individuals. In order to provide pain relief over a longer period of time, placing catheters near nerves has become a routine practice at the CHUM. Infraclavicular nerve block is one of the most widely used loco-regional anesthesia techniques for hand surgery. This block can be achieved either by paracoracoid (PC) or costoclavicular (CC) approach. Both approaches are currently used at the CHUM. The PC approach involves inserting a needle under the lower rim of the clavicle below the coracoid process. This approach makes it possible to reach the 3 different nerve bundles, located around the axillary artery, which are involved in the sensitivity of the hand. The CC approach, more recently described, proposes an insertion of the needle under the lower edge of the clavicle but in a lateral way to the axillary artery which makes it possible to reach the nerves at a place where the 3 main nerve bundles are still joined together. The clustering of nerve structures at the injection site may facilitate the spread of local anesthetics. Recent studies have demonstrated that the CC approach requires a smaller volume compared to the PC approach to achieve perineural blockade. The effective dose 90 (ED90) for the CC approach was 19 mL while it is 31 mL for the PC approach. This is explained by the greater proximity between the three nerve bundles targeted in the CC approach and a lower prevalence of anatomical variations at this level. However, studies on the subject are rare and do not allow conclusions to be drawn on the superiority of either approach.
Detailed Description
The aim of this study is to determine whether the costoclavicular approach (CC) provides a better sensory block 48 hours after catheter installation than the infraclavicular block performed by the paracoracoid approach (PC). In the context of continuous perineural blocks performed on an outpatient basis, LAs are delivered after insertion of a catheter by a low flow elastomeric pump (maximum 5 mL/h). Considering that the nerve structures are closer to each other with the CC approach, the investigators hypothesize that with the same mode of administration, the efficacy of the continuous block at 48 h obtained by the CC approach will be greater than the block produced by the PC approach. Methods Patients scheduled to undergo an upper limb surgery requiring a continuous infraclavicular nerve block will be contacted by a member of the research team before surgery to receive information regarding the study and obtain informed consent. After obtaining consent, participants will be randomly assigned to two groups: Group A: Placement of an infraclavicular perineural catheter by paracoracoid approach; Group B: Placement of an infraclavicular perineural catheter using a costoclavicular approach. Only the anesthesiologist performing the technique and his assistant will know the group to which the patient has been assigned. The blocks will be carried out in a standardized manner and in accordance with the establishment's procedures. After bringing the patient to the induction room and installing the recommended monitoring equipment, the anesthesiologist will administer an intravenous premedication. The patient will be installed in a supine position. After disinfecting the skin, the anesthesiologist will inject a small amount of local anesthetic to numb the skin in the area where the block will be performed and then locate the nerve bundles under ultrasound guidance using the approach to which the patient has been assigned (Group A or B). When the area has been located, the injection of a local anesthetic (bupivacaine) will be performed and the catheter installed and fixed. Multimodal analgesia will be used for postoperative pain relief including acetaminophen, non-steroidal anti-inflammatory drugs and hydromorphone as needed. Thirty minutes after the catheter insertion, a sensory-motor assessment of the blocked territory will be performed. During surgery, the patient may be sedated or receive general anesthesia at the discretion of the anesthesiologist. The surgery will be performed according to the usual procedure. In day-care surgery, a disposable elastomeric pump will be installed to ensure the perineural infusion of LA. The patient will receive the usual information about postoperative analgesia and the use of the pump. Follow-up details will be reviewed with the patient prior to discharge from hospital. A follow-up teleconsultation will be made the day after surgery and two days after surgery. As part of these calls, the following items will be assessed: sensory level and motor function of the forearm, level of pain and opioid use, presence of side effects, quality of sleep and satisfaction towards the analgesic technique used. All patients will benefit from a daily follow-up call by nurses from the Acute Pain Service (APS) for up to 72 hours. In the absence of adverse effects, catheters will be removed by patients 72 hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Local
Keywords
Infraclavicular perineural catheters, Hand surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, randomized controlled, triple blind
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Randomized, triple-blind controlled study (participant, surgeon and evaluator).
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infraclavicular nerve block using a costoclavicular approach
Arm Type
Active Comparator
Arm Description
The costoclavicular approach, more recently described, proposes an insertion of the needle under the lower edge of the clavicle but in a lateral way to the axillary artery which makes it possible to reach the nerves at a place where the 3 main nerve bundles are still joined together. The clustering of nerve structures at the injection site may facilitate the spread of local anesthetics.
Arm Title
Infraclavicular nerve block using a paracoracoid approach
Arm Type
Placebo Comparator
Arm Description
The paracoracoid approach involves inserting a needle under the lower rim of the clavicle below the coracoid process. This approach makes it possible to reach the 3 different nerve bundles, located around the axillary artery, which are involved in the sensitivity of the hand.
Intervention Type
Procedure
Intervention Name(s)
Placement of an infraclavicular perineural catheter using a costoclavicular approach
Intervention Description
The high-frequency linear probe will be used to image the axillary artery in the long axis and nearby nerve structures of interest, namely the posterior, lateral and medial bundles. The plane chosen will be located inferior to the clavicle, also in its distal third. The needle will be inserted with a latero-medial orientation in the plane. The initial injection will be a single injection laterally to the axillary artery, where the three nerve bundles are still joined together. The catheter will then be positioned and its location verified by injecting an additional 5 mL of bupivacaine into the catheter under direct ultrasound visualization. Catheter fixation will be standardized to minimize the risk of accidental displacement and the point of entry of the catheter to the skin will be covered with an opaque dressing.
Intervention Type
Procedure
Intervention Name(s)
Placement of an infraclavicular perineural catheter by paracoracoid approach
Intervention Description
The high-frequency linear probe will be used to image the axillary artery in the short axis and nearby nerve structures of interest, namely the posterior, lateral and medial bundles. The plane chosen will be located inferior to the clavicle, in its distal third. The needle will be inserted with a cranio-caudal orientation in the plane. The initial injection will be a single injection posterior to the axillary artery, the expected distribution being a "U" distribution around the artery. The catheter will then be positioned and its location verified by injecting an additional 5 mL of bupivacaine into the catheter under direct ultrasound visualization. Catheter fixation will be standardized to minimize the risk of accidental displacement and the point of entry of the catheter to the skin will be covered with an opaque dressing.
Primary Outcome Measure Information:
Title
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
Description
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm
Description
Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm (ulnar, median, radial, musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned according to the motor response (0 = Normal force compared to the contralateral side, 1 = Decrease in force (possible movement against gravity) compared to the contralateral side, 2 = no movement possible)
Time Frame
24 and 48 hours after surgery
Title
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
Description
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al. after the surgery. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).
Time Frame
24 hours after surgery
Title
Time to complete catheter placement
Description
The time needed to complete catheter placement by the anesthesiologist in seconds
Time Frame
Day of surgery, after catheter placement
Title
Occurrence of adverse events during the block
Description
The adverse events occurring during the block will be noted, such as vascular punctures, pneumothorax, paresthesias, repositioning for failure to raise the catheter through the needle.
Time Frame
Day of surgery, after catheter placement
Title
Rate of complete sensory block
Description
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm (ulnar, median, radial and musculocutaneous) using the score described by Boivin et al., 30 minutes after the catheter placement. A score of 0 to 2 will be assigned for each dermatome (0 = normal feeling; 1 = reduced sensation compared to the contralateral side (hypoesthesia); 2 = no feeling (anesthesia)).
Time Frame
Day of surgery, 30 minutes after catheter placement
Title
Rate of complete motor block
Description
Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm (ulnar, median, radial, musculocutaneous) using the score described by Boivin et al., 30 minutes after the catheter placement. A score of 0 to 2 will be assigned according to the motor response (0 = Normal force compared to the contralateral side, 1 = Decrease in force (possible movement against gravity) compared to the contralateral side, 2 = no movement possible)
Time Frame
Day of surgery, 30 minutes after catheter placement
Title
Worst pain during the block technique
Description
Worst pain during the block technique assessed using a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Time Frame
Day of surgery, after catheter placement
Title
Total opioid consumption
Time Frame
24 and 48 hours after surgery
Title
Time between the end of surgery and the first opioid dose
Time Frame
24 hours after surgery
Title
Minimum pain after the surgery
Description
Minimum pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Time Frame
24 and 48 hours after surgery
Title
Maximum pain after the surgery
Description
Maximum pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Time Frame
24 and 48 hours after surgery
Title
Average pain after the surgery
Description
Average pain reported by the patient, rated on a numerical scale where 0 = no pain and 10 = worst pain imaginable.
Time Frame
24 and 48 hours after surgery
Title
Percentage of time spent with moderate to severe pain
Description
Percentage of time spent with moderate to severe pain (> 4/10) using a numerical scale where 0 = no pain and 10 = worst pain imaginable
Time Frame
24 and 48 hours after surgery
Title
Rate of complications or adverse effects
Description
The rate of complications or adverse effects during the first 48 hours will be assessed, such as local anesthetic toxicity, nausea, vomiting, dizziness, drowsiness and accidental withdrawal of the catheter.
Time Frame
48 hours after surgery
Title
Quality of sleep
Description
The quality of sleep of the patient will be evaluated, rated on a scale where 0 = insomnia and 10 = excellent quality sleep.
Time Frame
24 hours and 48 hours after surgery
Title
Patient's satisfaction
Description
The satisfaction of the patient will be evaluated, rated on a scale where 0 = completely dissatisfied and 10 = fully satisfied.
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years old American Society of Anesthesiologists' classification 1 to 3 Patients undergoing elective ambulatory hand surgery requiring the use of continuous infraclavicular nerve block Exclusion Criteria: Contraindication to a peripheral nerve block Refusal of the patient or inability to consent Inability to communicate with the healthcare team or the research team Lack of access to the Teams telehealth platform Inability to understand the items of the different questionnaires Inability to understand ambulatory catheter follow-up instructions Pregnancy Obesity Body Mass Index > 40 Pre-existing neurological deficit in the operated upper limb Anatomical malformation not allowing one of the study blocks to be performed Condition preventing measurement of the primary outcome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxim Roy, MD, FRCPC
Phone
5148908000
Ext
12132
Email
maxim.roy20@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Desroches, PhD
Phone
5148908000
Ext
12172
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxim Roy, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Thiffault, RN, CCRP
Phone
5148908000
Ext
20113
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Julie Desroches, PhD
Phone
5148908000
Ext
12172
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca

12. IPD Sharing Statement

Learn more about this trial

A Comparison Between a PC and a CC Approach for the Placement of Infraclavicular Perineural Catheters in Hand Surgery

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