Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

NCT ID: NCT02506660

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-11-30

Brief Summary

Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.

Conditions

Pain; Shoulder Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous dexamethasone

Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Intravenous dexamethasone

Intervention Type: DRUG

Perineural saline

Intervention Type: DRUG

Saline in nerve block

Perineural dexamethasone

Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Perineural dexamethasone

Intervention Type: DRUG

Dexamethasone in nerve block

Intravenous saline

Intervention Type: DRUG

Interventions

Bupivacaine

Intervention Type: DRUG

Perineural dexamethasone

Dexamethasone in nerve block

Intervention Type: DRUG

Intravenous dexamethasone

Intervention Type: DRUG

Intravenous saline

Intervention Type: DRUG

Perineural saline

Saline in nerve block

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.)
• Age 18-70 years

Exclusion Criteria

• Contraindication to interscalene block
• Known allergy/sensitivity to any study medications
• Having taken daily steroids for 10 days or longer anytime during the past year
• Body mass index <18 or >40
• History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone)
• Non-English speaking
• Revision procedures
• Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.)
• Planned open procedures
• History of diabetes
• Arthroscopic irrigation and debridement secondary to infection
• Peripheral neuropathies affecting the operative extremity
• Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kahn

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

Kahn RL, Cheng J, Gadulov Y, Fields KG, YaDeau JT, Gulotta LV. Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial. Reg Anesth Pain Med. 2018 Aug;43(6):572-579. doi: 10.1097/AAP.0000000000000817.

Reference Type: DERIVED

PMID: 29889698 (View on PubMed)

Other Identifiers

2014-379

Identifier Type: -

Identifier Source: org_study_id