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Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT04085588
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Selim Turhanoglu, Mustafa Kemal University

Brief Summary:
This study evaluates continous infusion of low-dose ketamine during intraoperative and postoperative periods at three different doses to provide postoperative analgesia in total knee arthroplasty cases. Patients enrolled randomly into one of 2, 4, 6 μg / kg / min perioperative ketamine groups. All groups were given spinal anesthesia and intravenous patient controlled anesthesia. Ketamine was started when sensorial block reached T10 dermatome level before the skin incision. By the end of the operation, in all groups, ketamine infusions were reduced by half doses. Intravenous patient-controlled analgesia device was set to 2 mg bolus morphine with no basal infusion for 48 hours during the postoperative period.

Condition or disease
Postoperative Pain

Detailed Description:

Multimodal analgesia, which involves the administration of two or more analgesic agents targeting different levels of pain pathways, is used to improve pain control while also to reduce opioid use and related side effects. Pain can be treated at various neurophysiological levels, including peripheral, spinal and cortical targets. One of the agents used in the multimodal analgesia technique is ketamine.

Ketamine acts on the central nervous system (CNS) and has local anesthetic effect. Ketamine is an N-methyl D-Aspartate (NMDA) receptor antagonist, which appears to be the main mechanism of anesthetic and analgesic action at CNS and spinal cord receptors. Other mechanisms of action of ketamine include the interaction with opioid receptors, particularly mu and kappa receptors. Another effect is that it has local anesthetic effect in high doses. Studies have shown that ketamine is an effective agent in the treatment of postoperative pain. Continuous infusion of low-dose ketamine after total knee arthroplasty significantly reduced morphine consumption, and provided early rehabilitation without increasing side effects. However, when these studies are considered, there is no information about the optimal dose of ketamine that reduces opioid consumption at the highest level.

In our study, continuous infusion of low-dose ketamine at different doses was planned to provide postoperative analgesia. Therefore, our first aim in this study was to find out the optimal dose that reduced morphine consumption for postoperative analgesia after TKA with continuous ketamine infusion at different doses. The secondary objectives are to evaluate early and late period pain, side effects, length of hospital stay, patient satisfaction, and recovery.


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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty: Optimum Dose to Reduce Morphine Consumption
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Group/Cohort
Group 1

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them.

Before the skin incision, when sensorial block reached T10 dermatome level 2 μg / kg / min ketamine was started in Group 1. By the end of the operation ketamine infusion was reduced to 1 μg / kg / min.

Group 2

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them.

Before the skin incision, when sensorial block reached T10 dermatome level 4 μg / kg / min ketamine was started . By the end of the operation ketamine infusion was reduced to 2 μg / kg /min and continued.

Group 3

All patients were revived spinal anesthesia with 3 mL marcaine 0.5% and after surgery a 2 mg bolus morphine PCA pump was connected to them.

Before the skin incision, when sensorial block reached T10 dermatome level 6 μg / kg / min ketamine was started . By the end of the operation ketamine infusion was reduced to 3 μg / kg /min and continued.




Primary Outcome Measures :
  1. Optimal dose of Ketamine to reduce morphine consumption [ Time Frame: 48 hours from the operation ]
    Ketamine infusions 2μg 4μg and 6μg / kg / min will be started preoperatively in group 1, 2 and 3 respectively when sensory block level reaches T10 after spinal anesthesia, and they will be reduced by half by the end of the operation. Ketamine infusion will be continued for 48 hours postoperatively.


Secondary Outcome Measures :
  1. Early and late period pain [ Time Frame: 3 months from the operation ]
    The pain status of the patients at rest and in motion with 100 mm visual pain scale (VAS) (0= no pain and 100 = intolerable pain) will be evaluated and recorded preoperative and postoperative at 2nd, 6th, 12th, 24th and 48th hours.and after 3 months

  2. side effects, [ Time Frame: 3 months ]
    Nausea, vomiting, itching, respiratory depression, hallucination and diplopia

  3. length of hospital stay [ Time Frame: 3 months ]
    Hospital stay (as day) required for active knee flexion to 90 degrees (measured with goniometer) will be recorded.

  4. patient satisfaction [ Time Frame: 3 months ]
    5 point likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Being female or male can make difference in pain sensitivity and analgesic response. To facilitate of interpretation the results, only one gender (females) was included in the study.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
unilateral total knee arthroplasty cases
Criteria

Inclusion Criteria:

• ASA I-Ⅲ female patients scheduled for unilateral total knee arthroplasty

Exclusion Criteria:

  • Patients younger than 18 years of age
  • ASA Ⅳ and above patients
  • Having previous knee surgery on the same side
  • Patients with allergies to drugs to be used in the study
  • Contraindication for spinal anesthesia
  • Body mass index 40 kg / m2 and above patients
  • Opioid tolerance
  • Patients with neurological or psychiatric disorders
  • Patients who do not have the ability to use patient controlled analgesia device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085588


Contacts
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Contact: Selim Turhanoglu, M.D. +903262291000 adat63@gmail.com
Contact: Menekse Oksar, M.D. +903262291000 menekseoksar@gmail.com

Locations
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Turkey
Mustafa Kemal University Medical School Recruiting
Hatay, Turkey, 31100
Contact: Selim Turhanoglu, MD    +3262291000 ext 3062    adat63@gmail.com   
Contact: Sibel T Polat, M.D.    +903262291000    sibeltugce_aldik@hotmail.com   
Principal Investigator: Selim Turhanoglu, MD         
Sub-Investigator: Sibel T Polat, M.D.         
Sub-Investigator: Menekse Oksar, M.D.         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
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Study Director: Selim Turhanoglu, M.D. Mustafa Kemal University, Medical School, 31100 Hatay, Turkey

Publications of Results:
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Responsible Party: Selim Turhanoglu, Professor Doctor, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT04085588     History of Changes
Other Study ID Numbers: 15.04.2019-07
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing data have not been discussed among the investigators yet.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Selim Turhanoglu, Mustafa Kemal University:
Pain
analgesia
Postoperative
Ketamine
Morphine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action