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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
Sponsor:
Information provided by (Responsible Party):
Hande G. Aytuluk, Derince Training and Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Postoperative Pain
Intra-articular Injection
Dexmedetomidine
Magnesium Sulfate
Interventions Drug: Precedex
Drug: Magnesium Sulfate
Enrollment 62
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.
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 31 31
Completed 26 26
Not Completed 5 5
Reason Not Completed
Withdrawal by Subject             3             2
Physician Decision             2             3
Arm/Group Title Precedex Magnesium Sulfate Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
41.62
(18 to 65)
42.73
(23 to 59)
42.18
(18 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
6
  23.1%
4
  15.4%
10
  19.2%
Male
20
  76.9%
22
  84.6%
42
  80.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Turkey Number Analyzed 26 participants 26 participants 52 participants
26
 100.0%
26
 100.0%
52
 100.0%
1.Primary Outcome
Title Postoperative Pain
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Mean (Full Range)
Unit of Measure: score on a scale
VAS 2 R
0
(0 to 0)
0.04
(0 to 1)
VAS2 M
0.19
(0 to 2)
0.23
(0 to 2)
VAS4 R
0.81
(0 to 3)
0.12
(0 to 1)
VAS4 M
2.04
(0 to 6)
1.19
(0 to 3)
VAS6 R
1.50
(0 to 4)
1.31
(0 to 5)
VAS6 M
3.46
(0 to 8)
3.31
(0 to 8)
VAS8 R
1.23
(0 to 5)
1.77
(0 to 5)
VAS8 M
3.08
(0 to 8)
4.08
(1 to 8)
VAS12 R
0.73
(0 to 5)
1.15
(0 to 6)
VAS12 M
2.62
(0 to 6)
3.19
(2 to 8)
VAS18 R
0.23
(0 to 1)
0.27
(0 to 2)
VAS18 M
1.62
(0 to 4)
1.69
(0 to 4)
2.Secondary Outcome
Title Postoperative Opioid/NSAID Consumption
Hide Description nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Measure Type: Number
Unit of Measure: vials
NSAID 17 14
opioid 0 1
3.Secondary Outcome
Title Rescue Analgesic Time
Hide Description Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 15 13
Mean (Full Range)
Unit of Measure: minutes
477.33
(240 to 840)
498.46
(330 to 750)
4.Secondary Outcome
Title Surgery Time
Hide Description time from skin incision to closure
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Mean (Full Range)
Unit of Measure: minutes
24.23
(15 to 35)
25.58
(15 to 40)
5.Secondary Outcome
Title Time to the End of Spinal Anesthesia
Hide Description time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Mean (Full Range)
Unit of Measure: minutes
148.1
(60 to 320)
147.5
(70 to 300)
6.Secondary Outcome
Title Mobilization
Hide Description First mobilization time after surgery
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Mean (Full Range)
Unit of Measure: minutes
143.27
(75 to 300)
139.42
(75 to 300)
7.Secondary Outcome
Title Number of Participants With Complications Due to Intraarticular Injection
Hide Description post-injection complications due to intraarticular injection will be noted.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame an average of 1 month (from hospitalization to re-admissions due to complications (if any))
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Precedex Magnesium Sulfate
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Precedex Magnesium Sulfate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Precedex Magnesium Sulfate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Precedex Magnesium Sulfate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hande Aytuluk
Organization: Derince Training and Research Hospital
Phone: 00905336515650
Publications of Results:
Responsible Party: Hande G. Aytuluk, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03479216     History of Changes
Other Study ID Numbers: U1111-1211-1791
First Submitted: March 21, 2018
First Posted: March 27, 2018
Results First Submitted: August 9, 2018
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018