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

Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for

the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy

Study Overview

• Status: Completed
• Conditions: Arthroscopy
• Intervention / Treatment: Drug: Ketamine 0.5; Drug: Ketamine 1; Drug: % 0.9 NaCl

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: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Group 2
Sham Comparator: % 0.9 Saline; % 0.9 NaCL intraarticular injection	Drug: % 0.9 NaCl; Intraarticular %0.9 NaCl; Other Names: Group 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.
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.	Total amount off delivered morphine will be recorded for 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.

Collaborators and Investigators

• Sponsor: Balikesir University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ketamine; arthroscopy; Injection; Intra-Articular
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: osagir3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No