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

Primary Purpose

Arthroscopy

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ketamine 0.5

Ketamine 1

% 0.9 NaCl

About this trial

This is an interventional supportive care trial for Arthroscopy focused on measuring Injection, Intra-Articular, arthroscopy, ketamine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ketamine 0.5 mg/kg

Ketamine 1 mg/kg

% 0.9 Saline

Arm Description

ketamin 0.5 mg/kg intraarticular

ketamin 1 mg/kg intraarticular injection

% 0.9 NaCL intraarticular injection

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03955809

First Posted

May 14, 2019

Last Updated

January 19, 2020

Sponsor

Balikesir University

1. Study Identification

Unique Protocol Identification Number

NCT03955809

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Balikesir University

4. Oversight

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroscopy

Keywords

Injection, Intra-Articular, arthroscopy, ketamine

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine 0.5 mg/kg

Arm Type

Active Comparator

Arm Description

ketamin 0.5 mg/kg intraarticular

Arm Title

Ketamine 1 mg/kg

Arm Type

Active Comparator

Arm Description

ketamin 1 mg/kg intraarticular injection

Arm Title

% 0.9 Saline

Arm Type

Sham Comparator

Arm Description

% 0.9 NaCL intraarticular injection

Intervention Type

Drug

Intervention Name(s)

Ketamine 0.5

Other Intervention Name(s)

Group 1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine 1

Other Intervention Name(s)

Group 2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

% 0.9 NaCl

Other Intervention Name(s)

Group 3

Intervention Description

Intraarticular %0.9 NaCl

Primary Outcome Measure Information:

Title

Change in postoperative pain scores throughout time evaluated by VAS

Description

Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity

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.

Title

Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.

Description

The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.

Time Frame

Total amount off delivered morphine will be recorded for 24 hours.

Secondary Outcome Measure Information:

Title

Time for discharge measured by eligible for discharge criteria

Description

The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture)

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.

10. Eligibility

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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