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Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03479216
Enrollment
62
Registered
2018-03-27
Start date
2018-03-26
Completion date
2018-08-01
Last updated
2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Intra-articular Injection, Dexmedetomidine, Magnesium Sulfate

Keywords

Analgesia, Anesthesia, Arthroscopy, Bupivacaine, Dexmedetomidine, Injections, Intra-Articular, Magnesium, Pain, Postoperative

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.

Interventions

10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.

DRUGMagnesium Sulfate

10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.

Sponsors

Derince Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain24 hourspostoperative 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

MeasureTime frameDescription
Rescue Analgesic Time24 hoursTime to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Surgery Time24 hourstime from skin incision to closure
Postoperative Opioid/NSAID Consumption24 hoursnonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Mobilization24 hoursFirst mobilization time after surgery
Number of Participants With Complications Due to Intraarticular Injection24 hourspost-injection complications due to intraarticular injection will be noted.
Time to the End of Spinal Anesthesia24 hourstime from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

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)

Pre-assignment details

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.

Participants by arm

ArmCount
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.
26
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.
26
Total52

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision23
Overall StudyWithdrawal by Subject32

Baseline characteristics

CharacteristicMagnesium SulfateTotalPrecedex
Age, Continuous42.73 years42.18 years41.62 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Turkey
26 Participants52 Participants26 Participants
Sex: Female, Male
Female
4 Participants10 Participants6 Participants
Sex: Female, Male
Male
22 Participants42 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 26
other
Total, other adverse events
0 / 260 / 26
serious
Total, serious adverse events
0 / 260 / 26

Outcome results

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)

Time frame: 24 hours

Population: 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)

ArmMeasureGroupValue (MEAN)
PrecedexPostoperative PainVAS 2 R0 score on a scale
PrecedexPostoperative PainVAS4 M2.04 score on a scale
PrecedexPostoperative PainVAS2 M0.19 score on a scale
PrecedexPostoperative PainVAS12 M2.62 score on a scale
PrecedexPostoperative PainVAS6 M3.46 score on a scale
PrecedexPostoperative PainVAS4 R0.81 score on a scale
PrecedexPostoperative PainVAS8 R1.23 score on a scale
PrecedexPostoperative PainVAS18 R0.23 score on a scale
PrecedexPostoperative PainVAS8 M3.08 score on a scale
PrecedexPostoperative PainVAS6 R1.50 score on a scale
PrecedexPostoperative PainVAS12 R0.73 score on a scale
PrecedexPostoperative PainVAS18 M1.62 score on a scale
Magnesium SulfatePostoperative PainVAS18 M1.69 score on a scale
Magnesium SulfatePostoperative PainVAS4 R0.12 score on a scale
Magnesium SulfatePostoperative PainVAS4 M1.19 score on a scale
Magnesium SulfatePostoperative PainVAS12 R1.15 score on a scale
Magnesium SulfatePostoperative PainVAS12 M3.19 score on a scale
Magnesium SulfatePostoperative PainVAS18 R0.27 score on a scale
Magnesium SulfatePostoperative PainVAS 2 R0.04 score on a scale
Magnesium SulfatePostoperative PainVAS6 R1.31 score on a scale
Magnesium SulfatePostoperative PainVAS6 M3.31 score on a scale
Magnesium SulfatePostoperative PainVAS8 R1.77 score on a scale
Magnesium SulfatePostoperative PainVAS8 M4.08 score on a scale
Magnesium SulfatePostoperative PainVAS2 M0.23 score on a scale
Secondary

Mobilization

First mobilization time after surgery

Time frame: 24 hours

ArmMeasureValue (MEAN)
PrecedexMobilization143.27 minutes
Magnesium SulfateMobilization139.42 minutes
Secondary

Number of Participants With Complications Due to Intraarticular Injection

post-injection complications due to intraarticular injection will be noted.

Time frame: 24 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PrecedexNumber of Participants With Complications Due to Intraarticular Injection0 Participants
Magnesium SulfateNumber of Participants With Complications Due to Intraarticular Injection0 Participants
Secondary

Postoperative Opioid/NSAID Consumption

nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.

Time frame: 24 hours

ArmMeasureGroupValue (NUMBER)
PrecedexPostoperative Opioid/NSAID ConsumptionNSAID17 vials
PrecedexPostoperative Opioid/NSAID Consumptionopioid0 vials
Magnesium SulfatePostoperative Opioid/NSAID ConsumptionNSAID14 vials
Magnesium SulfatePostoperative Opioid/NSAID Consumptionopioid1 vials
Secondary

Rescue Analgesic Time

Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)

Time frame: 24 hours

Population: 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

ArmMeasureValue (MEAN)
PrecedexRescue Analgesic Time477.33 minutes
Magnesium SulfateRescue Analgesic Time498.46 minutes
Secondary

Surgery Time

time from skin incision to closure

Time frame: 24 hours

ArmMeasureValue (MEAN)
PrecedexSurgery Time24.23 minutes
Magnesium SulfateSurgery Time25.58 minutes
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)

Time frame: 24 hours

ArmMeasureValue (MEAN)
PrecedexTime to the End of Spinal Anesthesia148.1 minutes
Magnesium SulfateTime to the End of Spinal Anesthesia147.5 minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026