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

NCT04960046 | Completed

• 1 other identifier: 21.114
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Anesthesia, Local

Keywords

Infraclavicular perineural catheters; Hand surgery

Outcome Measures

Primary Outcomes (1)

• 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)).

  48 hours after surgery

Secondary Outcomes (16)

• Proportion of patients presenting a motor block score greater than or equal to 1 in the four main nervous territories of the forearm

  24 and 48 hours after surgery

• Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm

  24 hours after surgery

• Time to complete catheter placement

  Day of surgery, after catheter placement

• Occurrence of adverse events during the block

  Day of surgery, after catheter placement

• Rate of complete sensory block

  Day of surgery, 30 minutes after catheter placement

Study Arms (2)

Infraclavicular nerve block using a costoclavicular approach

ACTIVE COMPARATOR

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.

Procedure: Placement of an infraclavicular perineural catheter using a costoclavicular approach

Infraclavicular nerve block using a paracoracoid approach

PLACEBO COMPARATOR

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.

Procedure: Placement of an infraclavicular perineural catheter by paracoracoid approach

Interventions

Placement of an infraclavicular perineural catheter using a costoclavicular approach PROCEDURE

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.

Infraclavicular nerve block using a costoclavicular approach

Placement of an infraclavicular perineural catheter by paracoracoid approach PROCEDURE

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.

Infraclavicular nerve block using a paracoracoid approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Maxim Roy, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomized, triple-blind controlled study (participant, surgeon and evaluator).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, randomized controlled, triple blind

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: October 25, 2021
• Primary Completion: April 2, 2025
• Study Completion: April 4, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CA (1)