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

Overview

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

Full Title of Study: “Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Ketamine 0.5 mg/kg
    • ketamin 0.5 mg/kg intraarticular
  • Active Comparator: Ketamine 1 mg/kg
    • ketamin 1 mg/kg intraarticular injection
  • Sham Comparator: % 0.9 Saline
    • % 0.9 NaCL intraarticular injection

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Balikesir University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ozlem Sagir, MD, Associated Professor – Balikesir University

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