An interventional study of dexmedetomidine and ISB in Pain, sponsored by Chuncheon Sacred Heart Hospital. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Supportive care
The present study was designed to test the hypothesis that dexmedetomidine added to ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would enhance the duration and effect of analgesia when compared with ropivacaine alone, and their influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.
Background The incidence of severe postoperative pain after shoulder surgery is 30% to 70%.The postoperative pain should be relieved for early rehabilitation and recovery. Patient-controlled analgesia (PCA) with opiate therapy may control some of the postoperative pain, but it has several side effects such as nausea, vomiting, and dizziness, which can prevent early discharge. Conversely, there are several regional blocks to control postoperative pain. Interscalene brachial plexus block (ISB) is known as one of the most effective regional blocks for shoulder surgery, but it has relatively short duration of effect.
Dexmedetomidine (DEX), a selective agonist of α2-adrenergic receptors, can be an effective adjuvant to local anesthetics for peripheral nerve block. Preclinical and clinical studies have described prolonged duration of analgesia when dexmedetomidine was added to bupivacaine, levobupivacaine, or ropivacaine for peripheral perineural blocks.
Pro-inflammatory cytokines, such as interleukin-6 (IL-6), shows a high association with acute pain because they sensitize the nervous system. IL-6 levels in the plasma are detectable 60 minutes after injury, peaking at 4-6 hours, and are proportional to tissue injury.
Increased plasma cortisol concentrations can be detected within 15 minutes following exposure to a stressor. And several biomarkers related to pain have been studying.
Method 50 patients with rotator cuff tears who had undergone arthroscopic rotator cuff repairs were enrolled in this study. Rotator cuff tears were diagnosed by preoperative magnetic resonance imaging, and the size of the rotator cuff was confirmed at the time of arthroscopic operation. Indication for surgery was a symptomatic full-thickness rotator cuff tear or a partial thickness rotator cuff tear of more than 50% thickness in case of failed conservative therapy. Twenty-five patients were randomly allocated to group 1 and received both ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine . The other 25 patients were allocated to group 2 and received ISB with 8mL of ropivacaine with 1ml of normal saline.
Power analysis indicated that a total sample size of 46 patients (23 patients in each cohort) would provide a statistical power of 99% with a 2-sided a level of 0.05 to detect significant differences in the visual analog scale (VAS) score at 6 hours postoperatively, assuming an effect size of 0.88 (mean difference, 2.46, standard deviation, 2.8). This was based on the mean and standard deviation of the VAS at 6 hours postoperatively observed in a pilot study of 20 patients.
Double-blinded randomization was performed as follows. The remaining 50 patients were randomly assigned to 1 of 2 groups depending on the additional dexmedetomidine. Randomization was performed with a computerized random-sequence generator by an independent nurse who prepared a syringe for added dexmedetomidine or saline according to the assignment. The patients and all the medical staff who participated in the operation were blinded of the assignment.
VAS pain score, IL-6, cortisol, IL-1beta, IL-8, and substance p, height, and weight were checked preoperatively. All ISB were performed preemptively under ultrasonographic guidance. After sterile preparation and draping of the injection area, the structures of the brachial plexus were identified using ultrasound (Sonosite M-Turbo 13 mHz linear probe; Sonosite Corp, Bothell, Washington). Injections were performed using an out-of-plane technique using a plexus needle (Plexus Nano Line Uniplex, 22 gauge, 50 mm; Pajunk Corp, Geisingen, Germany). Nerve stimulation was not conducted.
PCA was set at a fixed dose (fentanyl, 0.05 mg/kg loading dose and 0.03 mg/min/kg continuous dose) to remove the effect of a variable amount of PCA. VAS pain score, IL-6, cortisol, IL-1beta, IL-8, and substance p, were checked 1, 6, 12, 24, and 48 hours postoperatively. VAS pain score was selected from 0 to 10, with 0 being no pain and 10 being the most severe pain that the patient had ever experienced.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Chuncheon Sacred Heart Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine
Drug: dexmedetomidine · Procedure: ISB · Drug: Ropivacaine
received ISB with 8mL of ropivacaine with 1ml of normal saline
Procedure: ISB · Drug: Ropivacaine
ISB with ropivacaine with dexmedetomidine or normal saline
Also known as: dexmedetomidine or normal saline
ISB with ropivacaine with dexmedetomidine or normal saline
Also known as: ISB for pain control
ISB with ropivacaine with dexmedetomidine or normal saline
Also known as: ISB using ropivacaine
change of five biomarkers (IL-6 in pg/ml, cortisol in ng/ml, IL-8 in pg/ml, IL-1beta in pg/ml, substance p in pg/ml) level due to pain after shoulder surgery.
Time frame: change from preoperation(baseline) IL-6, cortisol, IL-8, IL-1beta, and substance p level 1, 6, 12, 24, 48 hours after surgery due to postoperative pain
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexmedetomidine
Chuncheon Sacred Heart Hospital