The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair

May 5, 2016 updated by: Jae Jun Lee, Chuncheon Sacred Heart Hospital

The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Cortisol and IL-6 After Rotator Cuff Repair: a Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. a definite rotator cuff tear that needed repair seen on preoperative magnetic resonance imaging
  2. acceptance of arthroscopic surgery including rotator cuff repair
  3. age more than 20 years,
  4. acceptance of preemptive regional block , PCA and blood sampling after 1 ,6, 12, 24, 48 hour postoperatively. .

Exclusion Criteria:

  1. they did not undergo arthroscopic rotator cuff repair
  2. they stopped PCA before 48 hours postoperatively because of associated side effects
  3. there was a history of a previous shoulder operation or fracture
  4. there was a concomitant neurologic disorder around the shoulder
  5. refusal of blood sampling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: arm 1
received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine
Drug: dexmedetomidine
ISB with ropivacaine with dexmedetomidine or normal saline
Other Names:
  • dexmedetomidine or normal saline
Procedure: ISB
ISB with ropivacaine with dexmedetomidine or normal saline
Other Names:
  • ISB for pain control
Drug: Ropivacaine
ISB with ropivacaine with dexmedetomidine or normal saline
Other Names:
  • ISB using ropivacaine
Placebo Comparator: arm 2
received ISB with 8mL of ropivacaine with 1ml of normal saline
Procedure: ISB
ISB with ropivacaine with dexmedetomidine or normal saline
Other Names:
  • ISB for pain control
Drug: Ropivacaine
ISB with ropivacaine with dexmedetomidine or normal saline
Other Names:
  • ISB using ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Jae Jun Lee, M.D., Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital, College of Medicine, Hallym University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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