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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precedex | Experimental | 5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml) |
|
| Magnesium Sulfate | Experimental | 5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precedex | Drug | 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | 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) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid/NSAID Consumption | nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted. | 24 hours |
| Rescue Analgesic Time | Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tolga K Saracoglu, Ass Prof | Derince Training and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derince Training and Research Hospital | Kocaeli | Derince | 41900 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23881255 | Result | Sun R, Zhao W, Hao Q, Tian H, Tian J, Li L, Jia W, Yang K. Intra-articular clonidine for post-operative analgesia following arthroscopic knee surgery: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Sep;22(9):2076-84. doi: 10.1007/s00167-013-2615-8. Epub 2013 Jul 24. | |
| 26264382 | Result |
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52 patients aged between 18 and 65 years with ASA I or II who were scheduled for elective arthroscopic meniscectomy under spinal anesthesia were included in this prospective, randomized, double-blind study.
History of cardiac, hepatic or renal disorders, diabetes mellitus, chronic pain treatment, contraindication to/refusal of spinal anesthesia, a known allergy to the study drugs, or who refused to participate in the study were excluded.
(10 patients excluded: 5 declined regional anesthesia, 4 had diabetes mellitus,1 failure of regional anesthesia)
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| ID | Title | Description |
|---|---|---|
| FG000 | Precedex | 5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml) Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery. |
| FG001 | Magnesium Sulfate | 5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Precedex | 5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml) Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery. |
| BG001 | Magnesium Sulfate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain | 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) | visual analogue scale (VAS) scores at rest at 2nd hour (VAS2 R), 4th hour (VAS4 R), 6th hour (VAS6 R), 8th hour (VAS8 R), 12th hour (VAS12 R), 18th hour (VAS18 R) VAS scores at movement at 2nd hour (VAS2 M), 4th hour (VAS4 M), 6th hour (VAS6 M), 8th hour (VAS8 M), 12th hour (VAS12 M), 18th hour (VAS18 M) | Posted | Mean | Full Range | score on a scale | 24 hours |
|
an average of 1 month (from hospitalization to re-admissions due to complications (if any))
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Precedex | 5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml) Precedex: 10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hande Aytuluk | Derince Training and Research Hospital | 00905336515650 | handegrbz@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2018 | Oct 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002045 | Bupivacaine |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Magnesium Sulfate | Drug | 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. |
|
|
| 24 hours |
| Surgery Time | time from skin incision to closure | 24 hours |
| Time to the End of Spinal Anesthesia | time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0) | 24 hours |
| Mobilization | First mobilization time after surgery | 24 hours |
| Number of Participants With Complications Due to Intraarticular Injection | post-injection complications due to intraarticular injection will be noted. | 24 hours |
| Yang Y, Zeng C, Wei J, Li H, Yang T, Deng ZH, Li YS, Yang TB, Lei GH. Single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone after arthroscopic knee surgery: a meta-analysis of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):966-979. doi: 10.1007/s00167-015-3748-8. Epub 2015 Aug 12. |
| 17299013 | Result | Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13. |
| 25207314 | Result | Alipour M, Tabari M, Faz RF, Makhmalbaf H, Salehi M, Moosavitekye SM. Effect of dexmedetomidine on postoperative pain in knee arthroscopic surgery; a randomized controlled clinical trial. Arch Bone Jt Surg. 2014 Mar;2(1):52-6. Epub 2014 Mar 15. |
| 29068980 | Result | Li C, Qu J. Efficacy of dexmedetomidine for pain management in knee arthroscopy: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Oct;96(43):e7938. doi: 10.1097/MD.0000000000007938. |
| 29279832 | Result | Heydari SM, Hashemi SJ, Pourali S. The Comparison of Preventive Analgesic Effects of Ketamine, Paracetamol and Magnesium Sulfate on Postoperative Pain Control in Patients Undergoing Lower Limb Surgery: A Randomized Clinical Trial. Adv Biomed Res. 2017 Oct 25;6:134. doi: 10.4103/2277-9175.217217. eCollection 2017. |
| 28314555 | Result | Kizilcik N, Ozler T, Menda F, Ulucay C, Koner O, Altintas F. The effects of intra-articular levobupivacain versus levobupivacain plus magnesium sulfate on postoperative analgesia in patients undergoing arthroscopic meniscectomy: A prospective randomized controlled study. Acta Orthop Traumatol Turc. 2017 Mar;51(2):104-109. doi: 10.1016/j.aott.2017.02.014. Epub 2017 Mar 15. |
| 32265584 | Derived | Aytuluk HG, Gultekin A, Saracoglu KT. Comparison of intraarticular bupivacaine-dexmedetomidine and bupivacaine-magnesium sulfate for postoperative analgesia in arthroscopic meniscectomy: a randomized controlled clinical trial. Hippokratia. 2019 Apr-Jun;23(2):51-57. |
5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Magnesium Sulfate | 5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. |
|
|
| Secondary | Postoperative Opioid/NSAID Consumption | nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted. | Posted | Number | vials | 24 hours |
|
|
|
| Secondary | Rescue Analgesic Time | Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement) | Time to first analgesic demand at the orthopedics ward (from intra-articular injection to first analgesic requirement) was calculated in minutes among patients who required analgesics | Posted | Mean | Full Range | minutes | 24 hours |
|
|
|
| Secondary | Surgery Time | time from skin incision to closure | Posted | Mean | Full Range | minutes | 24 hours |
|
|
|
| Secondary | Time to the End of Spinal Anesthesia | time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0) | Posted | Mean | Full Range | minutes | 24 hours |
|
|
|
| Secondary | Mobilization | First mobilization time after surgery | Posted | Mean | Full Range | minutes | 24 hours |
|
|
|
| Secondary | Number of Participants With Complications Due to Intraarticular Injection | post-injection complications due to intraarticular injection will be noted. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Magnesium Sulfate | 5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) Magnesium Sulfate: 10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |