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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 : Completed
First Posted : September 11, 2019
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Selim Turhanoglu, Mustafa Kemal University

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 11, 2019
Last Update Posted Date September 14, 2021
Actual Study Start Date April 15, 2019
Actual Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 10, 2019)
  • 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
  • side effects, [ Time Frame: 3 months ]
    Nausea, vomiting, itching, respiratory depression, hallucination and diplopia
  • 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.
  • patient satisfaction [ Time Frame: 3 months ]
    5 point likert scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty
Official Title Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty: Optimum Dose to Reduce Morphine Consumption
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population unilateral total knee arthroplasty cases
Condition Postoperative Pain
Intervention Not Provided
Study Groups/Cohorts
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2019)
75
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2, 2021
Actual Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
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.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04085588
Other Study ID Numbers 15.04.2019-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Sharing data have not been discussed among the investigators yet.
Responsible Party Selim Turhanoglu, Mustafa Kemal University
Study Sponsor Mustafa Kemal University
Collaborators Not Provided
Investigators
Study Director: Selim Turhanoglu, M.D. Mustafa Kemal University, Medical School, 31100 Hatay, Turkey
PRS Account Mustafa Kemal University
Verification Date September 2021