NCT03479216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

March 21, 2018

Results QC Date

August 9, 2018

Last Update Submit

November 8, 2018

Conditions

Postoperative PainIntra-articular InjectionDexmedetomidineMagnesium Sulfate

Keywords

AnalgesiaAnesthesiaArthroscopyBupivacaineDexmedetomidineInjections, Intra-ArticularMagnesiumPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 hours

Secondary Outcomes (6)

  • Postoperative Opioid/NSAID Consumption

    24 hours

  • Rescue Analgesic Time

    24 hours

  • Surgery Time

    24 hours

  • Time to the End of Spinal Anesthesia

    24 hours

  • Mobilization

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

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)

Drug: Precedex

Magnesium Sulfate

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Interventions

PrecedexDRUG

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

Also known as: bupivacaine
Precedex
Magnesium SulfateDRUG

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

Also known as: bupivacaine
Magnesium Sulfate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18, \<65
  • scheduled for elective knee arthroscopy under spinal anesthesia
  • ASA I and ASA II

You may not qualify if:

  • age \<18 and \>65
  • patients who received general anesthesia
  • diabetes
  • refusal of the patient
  • known allergy to the specified drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, Derince, 41900, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 23881255RESULT

  • 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.

    PMID: 26264382RESULT

  • 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.

    PMID: 17299013RESULT

  • 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.

    PMID: 25207314RESULT

  • 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.

    PMID: 29068980RESULT

  • 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.

    PMID: 29279832RESULT

  • 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.

    PMID: 28314555RESULT

  • 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.

    PMID: 32265584DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

DexmedetomidineBupivacaineMagnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Dr. Hande Aytuluk
Organization
Derince Training and Research Hospital
handegrbz@gmail.com
00905336515650

Study Officials

  • Tolga K Saracoglu, Ass Prof

    Derince Training and Research Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

March 26, 2018

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

November 13, 2018

Results First Posted

November 13, 2018

Record last verified: 2018-11

Locations

TU(1)