Comparing two methods for inserting nerve blocks in shoulder surgery
Randomizes Control Trial (RCT): Superiority Study on Inter Scalene Block Execution Time for Shoulder Traumatology Surgery and Non-inferiority for Effectiveness Between Two Block Methods: Catheter Over Needle (CON) vs Catheter Through Needle (CTN).
This study is testing whether a new way to insert nerve blocks can be done faster than the traditional method for adults having shoulder surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago de Chile, Santiago) |
| Trial ID | NCT05960799 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the insertion times of two types of perineural catheters used for continuous nerve blocks in shoulder surgeries. The study will evaluate the Catheter Over Needle (CON) technique against the traditional Catheter Through Needle (CTN) method. The hypothesis is that the CON technique will allow for faster catheter insertion while maintaining similar effectiveness. Participants will be adult patients undergoing rotator cuff or proximal humerus surgery who consent to receive a peripheral nerve block.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing rotator cuff or proximal humerus surgery who are eligible for a peripheral nerve block.
Not a fit: Patients with coagulopathy, severe renal or hepatic disease, or those who refuse the postoperative continuous block technique may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to quicker and more efficient nerve block procedures for shoulder surgeries, improving patient comfort and surgical outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Rotator cuff or proximal humerus surgery * ASA I-III * BMI 18-39 kg/m2 * Acceptance of receiving a peripheric nerve block Exclusion Criteria: * Inability to provide consent for the study * Coagulopathy * Sepsis * Severe Renal or hepatic disease (Creatinin \> 2.0 or Child C) * Allergy to local anesthetics * Previous peripheral nerve damage * Refusal of postoperative continuous block technique
Where this trial is running
Santiago de Chile, Santiago
- Hospital clinico UC christus — Santiago de Chile, Santiago, Chile (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.