Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
Condition: Shoulder Injury
MeSH terms: Shoulder Injuries
Intervention: Ropivacaine; Dexamethasone; Dexamethasone; Normal saline; Normal saline
Intervention description: 25 ml ropivacaine 0.5%; 8 mg dexamethasone (perineural); 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous); 5 ml normal saline (intravenous); 0.8 ml normal saline (perineural)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ropivacaine; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain blockade; Ropivacaine; Dexamethasone

Summary:

      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 (1) ropivacaine and saline plus intravenous saline vs (2)
      ropivacaine and dexamethasone plus intravenous saline vs (3) 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.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients undergoing elective shoulder surgery by one of two surgeons highly
             experienced in the procedure.

          2. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to
             surgery (tramadol is permissible).

          3. Patients have an American Society of Anesthesiology physical status I-III.

        Exclusion criteria:

          1. Females who are pregnant.

          2. Patients who are taking chronic daily opiates for one month prior to surgery except
             tramadol.

          3. Diabetic patients.

          4. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males.

          5. Patients with contralateral pneumothorax or diaphragmatic paralysis.

          6. Patients with coagulopathy.

          7. Patients with clinically significant previous nerve injury in surgical extremity.

          8. Patients with an allergy to NSAIDs.

          9. Patients who are refusing a block.

         10. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block
             due to other medical condition such as severe chronic obstructive pulmonary disease
             (COPD).