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

Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955809
• Other study ID #: osagir3
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: January 2020
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopy
• Pain, Postoperative

Intervention

Drug:
• Ketamine 0.5
Intrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
• Ketamine 1
Intrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
• % 0.9 NaCl
Intraarticular %0.9 NaCl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.