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Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955809
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ozlem Sagir, MD, Balikesir University

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date January 22, 2020
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Change in postoperative pain scores throughout time evaluated by VAS [ Time Frame: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively. ]
    Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity
  • Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device. [ Time Frame: Total amount off delivered morphine will be recorded for 24 hours. ]
    The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Time for discharge measured by eligible for discharge criteria [ Time Frame: Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge. ]
The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
Official Title  ICMJE Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
Brief Summary the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy
Detailed Description

All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.

Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.

VAS scores and total analgesic requirement is going to be evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Arthroscopy
Intervention  ICMJE
  • Drug: Ketamine 0.5
    İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
    Other Name: Group 1
  • Drug: Ketamine 1
    İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
    Other Name: Group 2
  • Drug: % 0.9 NaCl
    Intraarticular %0.9 NaCl
    Other Name: Group 3
Study Arms  ICMJE
  • Active Comparator: Ketamine 0.5 mg/kg
    ketamin 0.5 mg/kg intraarticular
    Intervention: Drug: Ketamine 0.5
  • Active Comparator: Ketamine 1 mg/kg
    ketamin 1 mg/kg intraarticular injection
    Intervention: Drug: Ketamine 1
  • Sham Comparator: % 0.9 Saline
    % 0.9 NaCL intraarticular injection
    Intervention: Drug: % 0.9 NaCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Artroscopic surgery
  • ASA I-II

Exclusion Criteria:

  • Long time NSAID use
  • Travmatic knee injury
  • Long ter analgesic use
  • Intraartiular catheter insertion at the end of surgery
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955809
Other Study ID Numbers  ICMJE osagir3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ozlem Sagir, MD, Balikesir University
Study Sponsor  ICMJE Balikesir University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Balikesir University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP