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Completed

NCT Number: NCT03955809

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

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

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Key information

Conditions

Arthroscopy

Age range

18 year–75 year

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine 0.5

Drug

İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml

Other names: Group 1

Ketamine 1

Drug

İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml

Other names: Group 2

% 0.9 NaCl

Drug

Intraarticular %0.9 NaCl

Other names: Group 3

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
May 20, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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