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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Intra-articular Injection Dexmedetomidine Magnesium Sulfate||Drug: Precedex Drug: Magnesium Sulfate||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|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|
5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)
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
- 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)
- 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.
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
|Derince Training and Research Hospital|
|Kocaeli, Derince, Turkey, 41900|
|Study Chair:||Tolga K Saracoglu, Ass Prof||Derince Training and Research Hospital|