Postoperative Pain Clinical Trial
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.
NCT number | NCT04960046 |
Other study ID # | 21.114 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2021 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 134 |
Est. completion date | December 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
24 and 48 hours after surgery | |
Secondary | 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)). |
24 hours after surgery | |
Secondary | Time to complete catheter placement | The time needed to complete catheter placement by the anesthesiologist in seconds | Day of surgery, after catheter placement | |
Secondary | 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. | Day of surgery, after catheter placement | |
Secondary | 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)). |
Day of surgery, 30 minutes after catheter placement | |
Secondary | 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) |
Day of surgery, 30 minutes after catheter placement | |
Secondary | 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. | Day of surgery, after catheter placement | |
Secondary | Total opioid consumption | 24 and 48 hours after surgery | ||
Secondary | Time between the end of surgery and the first opioid dose | 24 hours after surgery | ||
Secondary | 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. | 24 and 48 hours after surgery | |
Secondary | 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. | 24 and 48 hours after surgery | |
Secondary | 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. | 24 and 48 hours after surgery | |
Secondary | 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 | 24 and 48 hours after surgery | |
Secondary | 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. | 48 hours after surgery | |
Secondary | 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. | 24 hours and 48 hours after surgery | |
Secondary | Patient's satisfaction | The satisfaction of the patient will be evaluated, rated on a scale where 0 = completely dissatisfied and 10 = fully satisfied. | 48 hours after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Recruiting |
NCT06007378 -
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT05943015 -
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
|
N/A | |
Completed |
NCT04544228 -
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
|
N/A | |
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Completed |
NCT05170477 -
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
|
N/A | |
Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
Not yet recruiting |
NCT04561856 -
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
|
Phase 4 | |
Completed |
NCT03612947 -
TAP Block in Laparoscopic Cholecystectomy.
|
Phase 2 | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Active, not recruiting |
NCT04190355 -
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
|
N/A | |
Recruiting |
NCT05145153 -
Incidence of Chronic Pain After Thoracic Surgery
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |