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

NCT ID: NCT03955809

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ketamine 0.5 mg/kg

ketamin 0.5 mg/kg intraarticular

Group Type ACTIVE_COMPARATOR

Ketamine 0.5

Intervention Type DRUG

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

Ketamine 1 mg/kg

ketamin 1 mg/kg intraarticular injection

Group Type ACTIVE_COMPARATOR

Ketamine 1

Intervention Type DRUG

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

% 0.9 Saline

% 0.9 NaCL intraarticular injection

Group Type SHAM_COMPARATOR

% 0.9 NaCl

Intervention Type DRUG

Intraarticular %0.9 NaCl

Interventions

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Ketamine 0.5

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

Intervention Type DRUG

Ketamine 1

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

Intervention Type DRUG

% 0.9 NaCl

Intraarticular %0.9 NaCl

Intervention Type DRUG

Other Intervention Names

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Group 1 Group 2 Group 3

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Sagir, MD

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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osagir3

Identifier Type: -

Identifier Source: org_study_id

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