Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT02322242
A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone.
Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M4N 3M5, Canada
Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion of dexamethasone (4mg)
Other names: Dexamethasone Sodium Phosphate Injection
Perinerual administration of dexamethasone (4mg)
Other names: Dexamethasone Sodium Phosphate Injection
Time frame: 1 day postoperative
Defined as time from completion of block procedure to NRS for pain > 0 (in hours)
Time frame: 1 day postoperative
Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours)
Time frame: 1 day postoperative
Defined as time from completion of block procedure to return to baseline motor function (in hours)
Time frame: 1 hour postoperative
Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better
Time frame: 7 days postoperative
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days
Time frame: 7 days postoperative
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Time frame: 1 hour postoperative
Measured 1 hour after arrival to the post-operative recovery room
Time frame: 7 Days postoperative
Defined as persistent paresthesia, and sensory/motor block at 7 days
Time frame: 7 Days postoperative
Number of participants with localized infection at nerve block site
Time frame: 7 days postoperative
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Dr. Stephen Choi
Other
Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial
Acronym: ISB-Dex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05499897
Postoperative Recovery, Rotator Cuff Injuries
Van, Bardakçı, Turkey (Türkiye)
View Trial DetailsNCT07449611
Interscalene Blocks, Perfusion Index
Sakarya, Turkey (Türkiye)
View Trial DetailsNCT05772533
Shoulder Surgery
Al Mansurah, Egypt
View Trial DetailsNCT06396455
Shoulder Surgery
Banhā, Egypt
View Trial Details