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

NCT03955809 | Completed Phase 4

• 1 other identifier: osagir3
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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

Conditions

Arthroscopy

Keywords

Injection; Intra-Articular; arthroscopy; ketamine

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (3)

Ketamine 0.5 mg/kg

ACTIVE COMPARATOR

ketamin 0.5 mg/kg intraarticular

Drug: Ketamine 0.5

Ketamine 1 mg/kg

ACTIVE COMPARATOR

ketamin 1 mg/kg intraarticular injection

Drug: Ketamine 1

% 0.9 Saline

SHAM COMPARATOR

% 0.9 NaCL intraarticular injection

Drug: % 0.9 NaCl

Interventions

Ketamine 0.5 DRUG

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

Also known as: Group 1

Ketamine 0.5 mg/kg

Ketamine 1 DRUG

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

Also known as: Group 2

Ketamine 1 mg/kg

% 0.9 NaCl DRUG

Intraarticular %0.9 NaCl

Also known as: Group 3

% 0.9 Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Artroscopic surgery
• ASA I-II

You may not qualify if:

• Long time NSAID use
• Travmatic knee injury
• Long ter analgesic use
• Intraartiular catheter insertion at the end of surgery

Sponsors & Collaborators

• Balikesir University: lead

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share