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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

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 27, 2018
Results First Submitted Date  ICMJE August 9, 2018
Results First Posted Date  ICMJE November 12, 2018
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE March 26, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Postoperative Pain [ Time Frame: 24 hours ]
    postoperative pain scores (ward)
  • postoperative opioid/NSAID consumption [ Time Frame: 24 hours ]
    nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.
  • Rescue Analgesic Time [ Time Frame: 24 hours ]
    Time to first analgesic demand at orthopedics ward (from intraarticular injection to first analgesic requirement)
Change History Complete list of historical versions of study NCT03479216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Postoperative Opioid/NSAID Consumption [ Time Frame: 24 hours ]
    nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
  • Rescue Analgesic Time [ Time Frame: 24 hours ]
    Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
  • Surgery Time [ Time Frame: 24 hours ]
    time from skin incision to closure
  • 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)
  • Mobilization [ Time Frame: 24 hours ]
    First mobilization time after surgery
  • Number of Participants With Complications Due to Intraarticular Injection [ Time Frame: 24 hours ]
    post-injection complications due to intraarticular injection will be noted.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Length of Stay [ Time Frame: maximum 24 hours ]
    length of hospital stay time will be noted
  • Complications Due to intraarticular injection [ Time Frame: 24 hours ]
    post-injection complications will be noted.
  • Mobilization [ Time Frame: 24 hours ]
    First mobilization time after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
Official Title  ICMJE Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Pain
  • Intra-articular Injection
  • Dexmedetomidine
  • Magnesium Sulfate
Intervention  ICMJE
  • Drug: Precedex
    10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
    Other Name: bupivacaine
  • Drug: Magnesium Sulfate
    10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
    Other Name: bupivacaine
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Precedex
  • Experimental: Magnesium Sulfate
    5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)
    Intervention: Drug: Magnesium Sulfate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2018)
62
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2018)
52
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479216
Other Study ID Numbers  ICMJE U1111-1211-1791
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: not decided yet
Responsible Party Hande G. Aytuluk, Derince Training and Research Hospital
Study Sponsor  ICMJE Derince Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tolga K Saracoglu, Ass Prof Derince Training and Research Hospital
PRS Account Derince Training and Research Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP