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Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

Primary Purpose

Postoperative Pain, Intra-articular Injection, Dexmedetomidine

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Precedex
Magnesium Sulfate
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Analgesia, Anesthesia, Arthroscopy, Bupivacaine, Dexmedetomidine, Injections, Intra-Articular, Magnesium, Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Derince Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Precedex

Magnesium Sulfate

Arm Description

5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)

5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Postoperative Opioid/NSAID Consumption
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Rescue Analgesic Time
Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Surgery Time
time from skin incision to closure
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)
Mobilization
First mobilization time after surgery
Number of Participants With Complications Due to Intraarticular Injection
post-injection complications due to intraarticular injection will be noted.

Full Information

First Posted
March 21, 2018
Last Updated
November 8, 2018
Sponsor
Derince Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03479216
Brief Title
Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
Official Title
Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Intra-articular Injection, Dexmedetomidine, Magnesium Sulfate
Keywords
Analgesia, Anesthesia, Arthroscopy, Bupivacaine, Dexmedetomidine, Injections, Intra-Articular, Magnesium, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precedex
Arm Type
Experimental
Arm Description
5ml 0.25% Bupivacaine ve 50mcg Dexmetedomidin (diluted to 5ml with normal saline) intraarticularly at the end of surgery (total volume: 10 ml)
Arm Title
Magnesium Sulfate
Arm Type
Experimental
Arm Description
5ml 0.25% Bupivacaine ve 5ml Magnesium Sulfate intraarticularly at the end of surgery (total volume: 10 ml)
Intervention Type
Drug
Intervention Name(s)
Precedex
Other Intervention Name(s)
bupivacaine
Intervention Description
10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
bupivacaine
Intervention Description
10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
Primary Outcome Measure Information:
Title
Postoperative Pain
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
Secondary Outcome Measure Information:
Title
Postoperative Opioid/NSAID Consumption
Description
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.
Time Frame
24 hours
Title
Rescue Analgesic Time
Description
Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)
Time Frame
24 hours
Title
Surgery Time
Description
time from skin incision to closure
Time Frame
24 hours
Title
Time to the End of Spinal Anesthesia
Description
time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)
Time Frame
24 hours
Title
Mobilization
Description
First mobilization time after surgery
Time Frame
24 hours
Title
Number of Participants With Complications Due to Intraarticular Injection
Description
post-injection complications due to intraarticular injection will be noted.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tolga K Saracoglu, Ass Prof
Organizational Affiliation
Derince Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Derince Training and Research Hospital
City
Kocaeli
State/Province
Derince
ZIP/Postal Code
41900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided yet
Citations:
PubMed Identifier
23881255
Citation
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.
Results Reference
result
PubMed Identifier
26264382
Citation
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.
Results Reference
result
PubMed Identifier
17299013
Citation
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. Erratum In: Ann Pharmacother. 2007 Mar;41(3):530-1.
Results Reference
result
PubMed Identifier
25207314
Citation
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.
Results Reference
result
PubMed Identifier
29068980
Citation
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.
Results Reference
result
PubMed Identifier
29279832
Citation
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.
Results Reference
result
PubMed Identifier
28314555
Citation
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.
Results Reference
result
PubMed Identifier
32265584
Citation
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.
Results Reference
derived

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Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain

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