Clinical trial NCT00801138: The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
Official title: The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, Local
Shoulder Surgery
Keywords: ropivacaine
bupivacaine
glucocorticoid
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.

Detailed description: This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:

* Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
* Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
* Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
* Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.

The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.

Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years
* Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression

Exclusion Criteria:

* Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
* Pregnancy
* Pre-existing neuropathy involving the surgical limb
* Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
* Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)

Primary outcomes:
measure: The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
timeFrame: Postoperative day 1, 2 and 3
Secondary outcomes:
measure: Time to First Report of Pain
timeFrame: Postoperative day 1, 2 and 3
measure: Median Maximum VAS Pain Scores at Rest
timeFrame: Postoperative day 1, 2 and 3
measure: Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
timeFrame: Postoperative day 1, 2 and 3
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kenneth Cummings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: Ivan Parra Sanchez, MD
role: STUDY_DIRECTOR
References: