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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomized, triple-blind controlled study (participant, surgeon and evaluator).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Infraclavicular nerve block using a costoclavicular approach
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.
干预措施: Placement of an infraclavicular perineural catheter using a costoclavicular approach (Procedure)
Infraclavicular nerve block using a paracoracoid approach
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.
干预措施: Placement of an infraclavicular perineural catheter by paracoracoid approach (Procedure)
结局指标
主要结局
Proportion of patients presenting at least a partial sensory block in the four main nervous territories of the forearm
时间窗: 48 hours after surgery
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)).
次要结局
- Minimum pain after the surgery(24 and 48 hours after surgery)
- 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)
- Worst pain during the block technique(Day of surgery, after catheter placement)
- Total opioid consumption(24 and 48 hours after surgery)
- Average pain after the surgery(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)
- Occurrence of adverse events during the block(Day of surgery, after catheter placement)
- Rate of complete motor block(Day of surgery, 30 minutes after catheter placement)
- Percentage of time spent with moderate to severe pain(24 and 48 hours after surgery)
- Rate of complete sensory block(Day of surgery, 30 minutes after catheter placement)
- Time to complete catheter placement(Day of surgery, after catheter placement)
- Time between the end of surgery and the first opioid dose(24 hours after surgery)
- Patient's satisfaction(48 hours after surgery)
- Quality of sleep(24 hours and 48 hours after surgery)
- Maximum pain after the surgery(24 and 48 hours after surgery)
- Rate of complications or adverse effects(48 hours after surgery)