Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
Primary Purpose
Arthroscopy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine 0.5
Ketamine 1
% 0.9 NaCl
Sponsored by
About this trial
This is an interventional supportive care trial for Arthroscopy focused on measuring Injection, Intra-Articular, arthroscopy, ketamine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Ketamine 0.5 mg/kg
Ketamine 1 mg/kg
% 0.9 Saline
Arm Description
ketamin 0.5 mg/kg intraarticular
ketamin 1 mg/kg intraarticular injection
% 0.9 NaCL intraarticular injection
Outcomes
Primary Outcome Measures
Change in postoperative pain scores throughout time evaluated by VAS
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.
The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
Secondary Outcome Measures
Time for discharge measured by eligible for discharge criteria
The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03955809
Brief Title
Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
Official Title
Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroscopy
Keywords
Injection, Intra-Articular, arthroscopy, ketamine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine 0.5 mg/kg
Arm Type
Active Comparator
Arm Description
ketamin 0.5 mg/kg intraarticular
Arm Title
Ketamine 1 mg/kg
Arm Type
Active Comparator
Arm Description
ketamin 1 mg/kg intraarticular injection
Arm Title
% 0.9 Saline
Arm Type
Sham Comparator
Arm Description
% 0.9 NaCL intraarticular injection
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.5
Other Intervention Name(s)
Group 1
Intervention Description
İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
Intervention Type
Drug
Intervention Name(s)
Ketamine 1
Other Intervention Name(s)
Group 2
Intervention Description
İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
Intervention Type
Drug
Intervention Name(s)
% 0.9 NaCl
Other Intervention Name(s)
Group 3
Intervention Description
Intraarticular %0.9 NaCl
Primary Outcome Measure Information:
Title
Change in postoperative pain scores throughout time evaluated by VAS
Description
Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity
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.
Title
Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
Description
The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
Time Frame
Total amount off delivered morphine will be recorded for 24 hours.
Secondary Outcome Measure Information:
Title
Time for discharge measured by eligible for discharge criteria
Description
The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture)
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.
10. Eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
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