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

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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

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

Condition or disease Intervention/treatment Phase
Arthroscopy Drug: Ketamine 0.5 Drug: Ketamine 1 Drug: % 0.9 NaCl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine 0.5 mg/kg
ketamin 0.5 mg/kg intraarticular
Drug: Ketamine 0.5
İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
Other Name: Group 1

Active Comparator: Ketamine 1 mg/kg
ketamin 1 mg/kg intraarticular injection
Drug: Ketamine 1
İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
Other Name: Group 2

Sham Comparator: % 0.9 Saline
% 0.9 NaCL intraarticular injection
Drug: % 0.9 NaCl
Intraarticular %0.9 NaCl
Other Name: Group 3




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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
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Responsible Party: Ozlem Sagir, MD, Associated Professor, Balikesir University
ClinicalTrials.gov Identifier: NCT03955809    
Other Study ID Numbers: osagir3
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ozlem Sagir, MD, Balikesir University:
Injection
Intra-Articular
arthroscopy
ketamine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action