Trial Outcomes & Findings for Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain (NCT NCT03479216)
NCT ID: NCT03479216
Last Updated: 2018-11-13
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
24 hours
Results posted on
2018-11-13
Participant Flow
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)
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Physician Decision
|
2
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.62 years
n=26 Participants
|
42.73 years
n=26 Participants
|
42.18 years
n=52 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
10 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=26 Participants
|
22 Participants
n=26 Participants
|
42 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
26 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
52 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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)
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)
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Postoperative Pain
VAS 2 R
|
0 score on a scale
Interval 0.0 to 0.0
|
0.04 score on a scale
Interval 0.0 to 1.0
|
|
Postoperative Pain
VAS2 M
|
0.19 score on a scale
Interval 0.0 to 2.0
|
0.23 score on a scale
Interval 0.0 to 2.0
|
|
Postoperative Pain
VAS4 R
|
0.81 score on a scale
Interval 0.0 to 3.0
|
0.12 score on a scale
Interval 0.0 to 1.0
|
|
Postoperative Pain
VAS4 M
|
2.04 score on a scale
Interval 0.0 to 6.0
|
1.19 score on a scale
Interval 0.0 to 3.0
|
|
Postoperative Pain
VAS6 R
|
1.50 score on a scale
Interval 0.0 to 4.0
|
1.31 score on a scale
Interval 0.0 to 5.0
|
|
Postoperative Pain
VAS6 M
|
3.46 score on a scale
Interval 0.0 to 8.0
|
3.31 score on a scale
Interval 0.0 to 8.0
|
|
Postoperative Pain
VAS8 R
|
1.23 score on a scale
Interval 0.0 to 5.0
|
1.77 score on a scale
Interval 0.0 to 5.0
|
|
Postoperative Pain
VAS8 M
|
3.08 score on a scale
Interval 0.0 to 8.0
|
4.08 score on a scale
Interval 1.0 to 8.0
|
|
Postoperative Pain
VAS12 R
|
0.73 score on a scale
Interval 0.0 to 5.0
|
1.15 score on a scale
Interval 0.0 to 6.0
|
|
Postoperative Pain
VAS12 M
|
2.62 score on a scale
Interval 0.0 to 6.0
|
3.19 score on a scale
Interval 2.0 to 8.0
|
|
Postoperative Pain
VAS18 R
|
0.23 score on a scale
Interval 0.0 to 1.0
|
0.27 score on a scale
Interval 0.0 to 2.0
|
|
Postoperative Pain
VAS18 M
|
1.62 score on a scale
Interval 0.0 to 4.0
|
1.69 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hoursnonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Postoperative Opioid/NSAID Consumption
NSAID
|
17 vials
|
14 vials
|
|
Postoperative Opioid/NSAID Consumption
opioid
|
0 vials
|
1 vials
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 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
Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Outcome measures
| Measure |
Precedex
n=15 Participants
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.
|
Magnesium Sulfate
n=13 Participants
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.
|
|---|---|---|
|
Rescue Analgesic Time
|
477.33 minutes
Interval 240.0 to 840.0
|
498.46 minutes
Interval 330.0 to 750.0
|
SECONDARY outcome
Timeframe: 24 hourstime from skin incision to closure
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Surgery Time
|
24.23 minutes
Interval 15.0 to 35.0
|
25.58 minutes
Interval 15.0 to 40.0
|
SECONDARY outcome
Timeframe: 24 hourstime from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Time to the End of Spinal Anesthesia
|
148.1 minutes
Interval 60.0 to 320.0
|
147.5 minutes
Interval 70.0 to 300.0
|
SECONDARY outcome
Timeframe: 24 hoursFirst mobilization time after surgery
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Mobilization
|
143.27 minutes
Interval 75.0 to 300.0
|
139.42 minutes
Interval 75.0 to 300.0
|
SECONDARY outcome
Timeframe: 24 hourspost-injection complications due to intraarticular injection will be noted.
Outcome measures
| Measure |
Precedex
n=26 Participants
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.
|
Magnesium Sulfate
n=26 Participants
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.
|
|---|---|---|
|
Number of Participants With Complications Due to Intraarticular Injection
|
0 Participants
|
0 Participants
|
Adverse Events
Precedex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Magnesium Sulfate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hande Aytuluk
Derince Training and Research Hospital
Phone: 00905336515650
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place