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Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

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ClinicalTrials.gov Identifier: NCT02698995
Recruitment Status : Unknown
Verified August 2016 by Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital

Brief Summary:
Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Ropivacaine Drug: Paracetamol Drug: Morphine Drug: Lidocaine Phase 3

Detailed Description:

The investigators conducted a prospective randomized controlled study in 150 patients American Society of Anesthesiologists (ASA) score I-III scheduled for upper limb surgery , divided in 3 groups: group A received anesthesia VIB block with ropivacaine 0,5% 100 mg +lidocaine 1%+1 ml saline; group B received VIB block with ropivacaine 0,5% 100 mg +lidocaine 1% + 2 mg dexamethasone; group C received ropivacaine 0,5% 100 mg +lidocaine 1% + 4 mg dexamethasone.The anesthesiologist may use the ultrasound for visual guidance, but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.

Intraoperative sedation was provided with intermittent bolus 10-20 mg IV Propofol. Postoperatively all patients received the same analgetic protocol when Visual Analog Pain Scale (VAS) over 3 with IV Perfalgan and Lornoxicam 8 mg/12 hours for 24 hours. If after 30 minutes VAS is still over 3, a loading dose of morphine 0,05 mg/kg should be administered. At first analgetic request, the nurse conducts an ice-probe test to both arms and will note the answer: same cold, slightly burn, burn, aching with the reason to test the potentially hyperalgesia effect related to ropivacaine. The data recorded are: time to first analgetic use, VAS at block regression, ice-probe test, motor and sensitive block duration, glycemic variations at 4 h, neurological complications immediately after block, total morphine consumption.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic Efficiency of Single-shot Perineural Low Dose Dexamethasone Added to Infraclavicular Block Anesthesia for Upper Limb Surgery
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group A
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin

Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Morphine Sulfate ER

Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine

Active Comparator: Group B
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Drug: Dexamethasone
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Decadron

Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin

Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Morphine Sulfate ER

Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine

Active Comparator: Group C
VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Drug: Dexamethasone
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Decadron

Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin

Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Name: Morphine Sulfate ER

Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine




Primary Outcome Measures :
  1. Sensory block duration [ Time Frame: First 24 hours ]
    The time in minutes measured between VIB block to first analgetic request


Secondary Outcome Measures :
  1. Motor block duration [ Time Frame: First 24 hours postoperatively ]
    The time in minutes measured between VIB block to complete movement of the hand

  2. Glycemic variations at 4 hours post-VIB block [ Time Frame: First 4 hours postoperatively ]
    Determination of blood sugar level

  3. Number of patients opioid free analgesia [ Time Frame: First 24 hours postoperatively ]
    Number of reported patients with no need opioid analgesia

  4. VAS at the block regression [ Time Frame: First 24 hours postoperatively ]
    VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )

  5. Cutaneous temperature ice-probe [ Time Frame: First 24 hours postoperatively ]
    The cold sensation on ice-probe test to both arms could be the same or burn likely

  6. Total morphine consumption at 24 hours [ Time Frame: First 24 hours postoperatively ]
    Cumulative morphine administration in milligrams



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III,
  • BMI<40,
  • non-anemic

Exclusion Criteria:

  • High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698995


Contacts
Contact: Ana Maria Munteanu, MD PhD 0040722514156 ammunteanu@gmail.com
Contact: Denisa Anastase, MD PhD 0040721255339 danastase1@gmail.com

Locations
Romania
Foisor Orthopedic Clinical Hospital Recruiting
Bucharest, Romania, 021383
Contact: Ana Maria Munteanu, MD PhD    0040722514156    ammunteanu@gmail.com   
Contact: Denisa Anastase, MD PhD    0040721255339    danastase1@gmail.com   
Sub-Investigator: Simona Florescu Cionac, MD PhD         
Sub-Investigator: Ioan Cristian Stoica, MD Prof         
Sponsors and Collaborators
Foisor Orthopedics Clinical Hospital
Investigators
Study Director: Ioan Cristian Stoica, MD Prof Foisor Orthopedics Clinical Hospital

Publications of Results:
Responsible Party: Munteanu Ana Maria, MD, PhD, MD PhD, Foisor Orthopedics Clinical Hospital
ClinicalTrials.gov Identifier: NCT02698995     History of Changes
Other Study ID Numbers: ID AN-002-14
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Lidocaine
Morphine
Ropivacaine
Acetaminophen
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics