Postoperative PainPhase 4NCT03479216
Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
A Phase 4 study testing Precedex and Magnesium Sulfate in people with Postoperative Pain and Intra-articular Injection, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Intra-articular Injection, Dexmedetomidine
- What is being tested?
- Precedex and Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2018to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18, <65
- scheduled for elective knee arthroscopy under spinal anesthesia
- ASA I and ASA II
Who cannot join
- age <18 and >65
- patients who received general anesthesia
- diabetes
- refusal of the patient
- known allergy to the specified drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli, Derince, 41900
About this study
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.
Read the 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.
- Being tested
- Precedex, Magnesium Sulfate
- Keywords
- Analgesia, Anesthesia, Arthroscopy, Bupivacaine, Dexmedetomidine, Injections, Intra-Articular, Magnesium, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Also called bupivacaine
10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
Magnesium SulfateDrug
Also called bupivacaine
10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Precedex |
| Magnesium Sulfate | Experimental | 5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (6)
Postoperative Opioid/NSAID Consumption
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Measured: 24 hours
Rescue Analgesic Time
Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Measured: 24 hours
Surgery Time
time from skin incision to closure
Measured: 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)
Measured: 24 hours
Mobilization
First mobilization time after surgery
Measured: 24 hours
Number of Participants With Complications Due to Intraarticular Injection
post-injection complications due to intraarticular injection will be noted.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start26 Mar 2018
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande G. Aytuluk, Derince Training and Research Hospital
- Investigators
- Tolga K Saracoglu, Ass Prof, Study chair, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479216
- Sponsor's protocol ID
- U1111-1211-1791
- Status last verified
- Nov 2018
- First submitted
- 21 Mar 2018
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet
Publications
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.
PubMed 23881255Yang 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.
PubMed 26264382Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13.
PubMed 17299013Alipour 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.
PubMed 25207314Li 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.
PubMed 29068980Heydari 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.
PubMed 29279832Kizilcik 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.
PubMed 28314555Aytuluk 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.
PubMed 32265584
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
- ClinicalTrials.gov ID
- NCT03479216
- Acronym / sponsor ID
- U1111-1211-1791
- Keywords
- Analgesia, Anesthesia, Arthroscopy, Bupivacaine, Dexmedetomidine, Injections, Intra-Articular, Magnesium, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precedex | Experimental | Drug: Precedex5ml 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 | Drug: Magnesium Sulfate5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18, <65
- scheduled for elective knee arthroscopy under spinal anesthesia
- ASA I and ASA II
Key exclusion criteria (5 listed)
- age <18 and >65
- patients who received general anesthesia
- diabetes
- refusal of the patient
- known allergy to the specified drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrecedexAlso: bupivacaine10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery. | Drug | Precedex |
| Magnesium SulfateAlso: bupivacaine10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery. | Drug | Magnesium Sulfate |
Primary outcome
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)
6 secondary outcomes
Postoperative Opioid/NSAID Consumption
Time frame: 24 hours
Rescue Analgesic Time
Time frame: 24 hours
Surgery Time
Time frame: 24 hours
Time to the End of Spinal Anesthesia
Time frame: 24 hours
Mobilization
Time frame: 24 hours
Number of Participants With Complications Due to Intraarticular Injection
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23881255Sun 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.
- Results publication: PubMed 26264382Yang 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.
- Results publication: PubMed 17299013Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13.
- Results publication: PubMed 25207314Alipour 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.
- Results publication: PubMed 29068980Li 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.
- Results publication: PubMed 29279832Heydari 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.
- Results publication: PubMed 28314555Kizilcik 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.
- Derived from this study: PubMed 32265584Aytuluk 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.
- Individual participant dataSharing planned: Undecided. not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tolga K Saracoglu, Ass Prof study chair
Derince Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precedex and Magnesium Sulfate in people with Postoperative Pain and Intra-articular Injection, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479216, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.