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

Phase 4

Completed

• Conditions: Arthroscopy
• Interventions: Drug: Ketamine 1; Drug: Ketamine 0.5; Drug: % 0.9 NaCl

• Registration Number: NCT03955809
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2016-08
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine 1 mg/kg	Ketamine 1	ketamin 1 mg/kg intraarticular injection
Ketamine 0.5 mg/kg	Ketamine 0.5	ketamin 0.5 mg/kg intraarticular
% 0.9 Saline	% 0.9 NaCl	% 0.9 NaCL intraarticular injection

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain scores throughout time evaluated by VAS	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.	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

Name	Time	Method
Time for discharge measured by eligible for discharge criteria	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)