Ropivacaine Block Alone or with Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 11-001266
NCT ID: NCT01450007
Sponsor Protocol Number: 11-001266
About this study
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site.
This study is a prospective, randomized, double-blind, controlled study to compare pain block with
- ropivacaine and saline plus intravenous saline vs
- ropivacaine and dexamethasone plus intravenous saline vs
- ropivacaine and saline plus intravenous dexamethasone.
Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients are either males or non-pregnant females ≥18 years old undergoing elective arthroscopic rotator cuff repair by one of two surgeons highly experienced in the procedure.
- Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible).
- Patients have an American Society of Anesthesiology physical status I-III.
- Females who are pregnant.
- Patients who are taking chronic daily opiates for one month prior to surgery except tramadol.
- Diabetic patients.
- Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.
- Patients with contralateral pneumothorax or diaphragmatic paralysis.
- Patients with coagulopathy.
- Patients with clinically significant previous nerve injury in surgical extremity.
- Patients with an allergy to NSAIDs.
- Patients who are refusing a block.
- Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe COPD.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.