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

• ClinicalTrials.gov Identifier: NCT03955809
• Recruitment Status: Completed
• First Posted: May 20, 2019
• Last Update Posted: January 22, 2020
• Sponsor: Balikesir University
• Information provided by (Responsible Party): Ozlem Sagir, MD, Balikesir University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Arthroscopy	Drug: Ketamine 0.5; Drug: Ketamine 1; Drug: % 0.9 NaCl	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
• Study Start Date: August 2013
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Ozlem Sagir, MD, Associated Professor, Balikesir University
• ClinicalTrials.gov Identifier: NCT03955809
• Other Study ID Numbers: osagir3
• First Posted: May 20, 2019
• Last Update Posted: January 22, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ozlem Sagir, MD, Balikesir University:

Injection; Intra-Articular; arthroscopy; ketamine

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action