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Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03479216
Recruitment Status : Completed
First Posted : March 27, 2018
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hande G. Aytuluk, Derince Training and Research Hospital

Brief Summary:
Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. The objective of the study is to compare the effects of intraarticular local anesthetic and adjuvant (dexmedetomidine vs magnesium) combinations in postoperative pain and analgesic requirement. The investigators' hypothesis is adjuvants added to the local anesthetics decreases the total local anesthetic dose, provides more effective pain relief according to local anesthetic only, and decreases the postoperative systemic non-steroidal analgesic and opioid doses.

Condition or disease Intervention/treatment Phase
Postoperative Pain Intra-articular Injection Dexmedetomidine Magnesium Sulfate Drug: Precedex Drug: Magnesium Sulfate Phase 4

Detailed Description:

Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. However, irritation of free nerve endings in the synovial tissue and anterior fat pads and stretching and resection in the joint capsule lead to pain at various levels. Proper pain management enhances recovery, provides early mobilization and shortens length of hospital stay.

"Opioid-free" analgesia methods are frequently emphasized in published postoperative pain management guidelines and multimodal treatment approaches such as local anesthetic infiltration is recommended. In the treatment of knee pain, intra-articular drug injections are the most commonly used method because of minimal systemic side effects.

The drugs most commonly administered intraarticularly included local anesthetics (bupivacaine, levobupivacaine, lidocaine), opioids (morphine, fentanyl), magnesium sulfate, steroids, and α2 agonists (clonidine, dexmedetomidine).

Dexmedetomidine is a selective, specific, lipophilic and potent α2 adrenergic receptor agonist with sedative, anxiolytic, analgesic, antihypertensive and sympatholytic effects. It provides analgesic activity through both the central and peripheral nervous system. The analgesic effects of intra-articular administration of dexmedetomidine in arthroscopic surgeries have been demonstrated. Most side effects of this drug included hypotension and bradycardia. However, these side effects have never been encountered with intra-articular injection of the drug.

Magnesium is also an adjuvant drug which has a key role in nociceptive transmission, and acts as a NMDA (N-Methyl-D-Aspartate) antagonist in spinal neurons.

While opioid free anesthesia and analgesia methods gain importance nowadays, there has been increased interest in non-opioid analgesic drugs and multimodal analgesia applications. In order to increase the effects of local anesthetics and prolong their analgesic times, the addition of various adjuvants to local anesthetics is frequently used.

In the randomized controlled trials, intraarticular local anesthetic drugs combined with adjuvant drugs for postoperative analgesia were found to be superior to local anesthetic drugs alone. It is also known that local anesthetics have negative effects on chondrocytes. One of the goals of the investigators' in this study is to reduce the amount of local anesthetic used by adding adjuvant to local anesthetics.

In this study, the investigators plan to compare the efficacy of 2 adjuvants (magnesium sulfate and dexmedetomidine) combined with local anesthetics to be given intraarticularly for postoperative pain management after elective arthroscopic surgery.

Intraarticular high-volume drug injections may cause pain due to tension in the joint capsule. Additionally, the investigators aim to decrease the total drug volume with adjuvant drugs used in combination with local anesthetic, and thus to prevent joint capsule tension pain.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : August 1, 2018


Arm Intervention/treatment
Experimental: Precedex
5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)
Drug: Precedex
10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
Other Name: bupivacaine

Experimental: Magnesium Sulfate
5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)
Drug: Magnesium Sulfate
10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
Other Name: bupivacaine




Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 24 hours ]
    postoperative pain scores (rest and movement) (ward) Pain scores were assessed with a 10-cm Visual Analogue Scale (VAS) (with 0 = no pain and 10 = the worst imaginable pain)


Secondary Outcome Measures :
  1. Postoperative Opioid/NSAID Consumption [ Time Frame: 24 hours ]
    nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.

  2. Rescue Analgesic Time [ Time Frame: 24 hours ]
    Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)

  3. Surgery Time [ Time Frame: 24 hours ]
    time from skin incision to closure

  4. Time to the End of Spinal Anesthesia [ Time Frame: 24 hours ]
    time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)

  5. Mobilization [ Time Frame: 24 hours ]
    First mobilization time after surgery

  6. Number of Participants With Complications Due to Intraarticular Injection [ Time Frame: 24 hours ]
    post-injection complications due to intraarticular injection will be noted.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18, <65
  • scheduled for elective knee arthroscopy under spinal anesthesia
  • ASA I and ASA II

Exclusion Criteria:

  • age <18 and >65
  • patients who received general anesthesia
  • diabetes
  • refusal of the patient
  • known allergy to the specified drugs

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): NCT03479216


Locations
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Turkey
Derince Training and Research Hospital
Kocaeli, Derince, Turkey, 41900
Sponsors and Collaborators
Derince Training and Research Hospital
Investigators
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Study Chair: Tolga K Saracoglu, Ass Prof Derince Training and Research Hospital
  Study Documents (Full-Text)

Documents provided by Hande G. Aytuluk, Derince Training and Research Hospital:

Publications of Results:

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Responsible Party: Hande G. Aytuluk, Principal Investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03479216     History of Changes
Other Study ID Numbers: U1111-1211-1791
First Posted: March 27, 2018    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not decided yet

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Hande G. Aytuluk, Derince Training and Research Hospital:
Analgesia
Anesthesia
Arthroscopy
Bupivacaine
Dexmedetomidine
Injections, Intra-Articular
Magnesium
Pain, Postoperative

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Magnesium Sulfate
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Tocolytic Agents