Comparing two types of nerve blocks for pain relief after shoulder surgery
A Randomized Comparison Between Interscalene And Combined Infraclavicular-Anterior Suprascapular Nerve Blocks For Arthroscopic Shoulder Surgery
This study is testing whether a new type of nerve block for pain relief after shoulder surgery works just as well as a standard one but with less risk of side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Chile Academic / other |
| Locations | 1 site (Santiago, Metropolitana) |
| Trial ID | NCT05444517 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of the interscalene block (ISB) and a combined infraclavicular-anterior suprascapular nerve block (ICB-ASSNB) for providing postoperative analgesia in patients undergoing arthroscopic shoulder surgery. The study hypothesizes that ICB-ASSNB can deliver similar pain relief to ISB while minimizing the risk of hemidiaphragmatic paralysis, a common complication associated with ISB. Participants will be randomly assigned to receive one of the two nerve blocks, and their pain levels will be assessed 30 minutes post-surgery to evaluate the equivalence of analgesia provided by both techniques.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing arthroscopic shoulder surgery with an ASA classification of 1-3 and a BMI between 20 and 35.
Not a fit: Patients with pre-existing neuropathy, coagulopathy, significant pulmonary disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer alternative for pain management in shoulder surgery patients, particularly those with preexisting pulmonary issues.
How similar studies have performed: While diaphragm-sparing nerve blocks have been proposed, none have shown equivalent analgesia to ISB without the risk of hemidiaphragmatic paralysis, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing arthroscopic shoulder surgery * American Society of Anesthesiologists classification 1-3 * Body mass index between 20 and 35 kg/mt2 Exclusion Criteria: * Adults who are unable to give their own consent * Pre-existing neuropathy (assessed by history and physical examination) * Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50) * Obstructive or restrictive pulmonary disease (assessed by history and physical examination) * Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * Allergy to local anesthetics (LAs) * Pregnancy * Prior surgery in the neck or infraclavicular region * Chronic pain syndromes requiring opioid intake at home
Where this trial is running
Santiago, Metropolitana
- Hospital Clínico Universidad de Chile — Santiago, Metropolitana, Chile (Recruiting)
Study contacts
- Principal investigator: Julián Aliste, MD — University of Chile
- Study coordinator: Julián Aliste, MD
- Email: julian.aliste@uchile.cl
- Phone: +56229788221
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.