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The Pre-Emptive Administration Of Ketamine for Controlling Post-thoracotomy Pain

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ClinicalTrials.gov Identifier: NCT03415191
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Alfonso Fiorelli, University of Campania "Luigi Vanvitelli"

Tracking Information
First Submitted Date  ICMJE January 15, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date January 30, 2018
Actual Study Start Date  ICMJE January 5, 2012
Actual Primary Completion Date December 21, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Change From Baseline in Pain Scores on the Visual Analog Scale at 48 hours [ Time Frame: 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after suregry ]
The primary end-point was to evaluate whether ketamine was able to reduce the postoperative pain at the first 48 post-operative hours, compared to placebo. The pain levels were scored using a Visual Analogue scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Change From Baseline in c-Reactive Protein (CRP) serum levels at 48 hours [ Time Frame: 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours following surgery. ]
    The inflammatory response was represented by the measurements of c-Reactive Protein (CRP) serum levels in both arms
  • Change From Baseline in morphine consumption at 48 hours [ Time Frame: 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours of postoperative course. ]
    Cumulative dose of morphine consumption (in mg) was registered in post-operative course
  • Indicence of clinical adverse effect in the entire post operative course [ Time Frame: entire post-operative course ]
    blurred vision, hallucination, nightmares, vertigo, or nausea and vomiting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pre-Emptive Administration Of Ketamine for Controlling Post-thoracotomy Pain
Official Title  ICMJE Is The Pre-Emptive Administration Of Ketamine A Significant Adjunction To Intravenous Morphine Analgesia For Controlling Post-Operative Pain? A Randomized, Double Blind, Placebo Controlled Clinical Trial.
Brief Summary The goal of this paper is to evaluate whether the pre-emptive administration of Ketamine would potentiate the effect of intravenous morphine analgesia in management of post thoracotomy pain. This was a single center, double-blind, placebo controlled, parallel-group, prospective study. Patients were randomly assigned to receive 1 mg/kg ketamine (Ketamine Group) or an equivalent dose of normal saline (Placebo Group) before thoracotomy in 1:1 ratio. All patients received postoperatively intravenous morphine administration as additional analgesic regimen Primary end-point was pain relief measured with Visual Analogue Scale at rest. The secondary end-points were the reduction of inflammatory response expressed by plasma c-reactive protein levels, the morphine consumption, and the rate of side effects. The measurements were carried out 6; 12; 24; 36; and 48 post operative hours.
Detailed Description

Thoracotomy is one of the most painful surgical incision. Inadequate control of pain can have several detrimental effects, including increased postoperative morbidity and delayed recovery as well as occurrence of post thoracotomy syndrome. Therefore, choosing an effectiveness analgesic regimen for thoracic surgery is critical. Many strategies including intercostal nerve block, intra pleural analgesia, lumbar or thoracic epidural, paravertebral block, intra venous narcotics, intrathecal or epidural narcotics or trans-cutaneous nerve stimulation have been used with varied success. However, the ideal strategy remains an open issue. Different factors including trauma of chest wall, thoracic viscera, diaphragm, and intercostal nerves concur to thoracotomy pain development. Thus, due to multifactorial genesis of pain following thoracotomy a multimodal analgesic approach rather than a single method seems to be more effective because it blocks noxious input at different targets and levels of pain pathways.

Ketamine is an antagonist of N-methyl-D-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies. In thoracic surgery, there are contradictory results on the efficacy of ketamine for controlling pain due to different dose, type of surgery/patient, and postoperative analgesic regimen used in the various studies. Mathew et al. in a recent review concluded that adding low-dose ketamine to intravenous morphine analgesia following thoracotomy was safe and could provide a significant better pain relief and reduction of morphine consumption compared to placebo. D'Alonzo et al. found that the administration of a single dose of ketamine prior to chest incision failed to significantly reduce the pain scores and inflammation in the first 24 post-operative hours. Similarly, Yazigi et al. reported that pre-emptive intravenous low-dose ketamine followed by continuous administration during surgery did not decrease acute pain scores and supplemental morphine consumption. Other studies reported that the epidural infusion of Ketamine before thoracotomy or during thoracic surgery provides better postoperative analgesia compared to placebo group or epidural ropivacaine group In the present study, the investigators supposed that the pre-emptive administration of Ketamine would potentiate the effect of intravenous opioid analgesia with reduction of pain scores, inflammatory response and morphine consumption without increasing morbidity in patients undergoing thoracotomy.

This was a single center, double-blind, placebo controlled, parallel-group, prospective study. Patients were randomly assigned to receive 1 mg/kg ketamine (Ketamine Group) or an equivalent dose of normal saline (Placebo Group) before thoracotomy in 1:1 ratio. All patients received postoperatively intravenous morphine administration as additional analgesic regimen Primary end-point was pain relief measured with Visual Analogue Scale at rest. The secondary end-points were the reduction of inflammatory response expressed by plasma c-reactive protein levels, the morphine consumption, and the rate of side effects. The measurements were carried out 6; 12; 24; 36; and 48 post operative hours.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This was a single center, double-blind, placebo controlled, parallel-group, prospective study. Patients were randomly assigned to Ketamine or Placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were attended.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Thoracotomy Pain
Intervention  ICMJE
  • Drug: Ketamine
    A bolus dose of ketamine 1 mg/kg intravenously five minutes before surgical incision
  • Drug: Normal Saline
    A bolus dose of normal saline 1 mg/kg intravenously five minutes before surgical incision
Study Arms  ICMJE
  • Experimental: Ketamine Group
    Five minutes before thoracotomy incision, Ketamine Group received a bolus dose of ketamine 1 mg/kg intravenously
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo Group
    Five minutes before thoracotomy incision, Placebo Group received a bolus dose of normal saline 1 mg/kg intravenously
    Intervention: Drug: Normal Saline
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2015
Actual Primary Completion Date December 21, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged more than 18 years old,
  • planned for an elective partial pneumonectomy (partial or total lobectomy involving one or more lobes, except total pneumonectomy)
  • standard lateral thoracotomy for management of non small cell lung cancer (NSCLC)

Exclusion Criteria:

  • allergy to Ketamine
  • ASA score more than 3
  • previous thoracic surgical procedures or lung resection
  • mental disease
  • participation to other studies
  • lack of written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415191
Other Study ID Numbers  ICMJE 513/12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alfonso Fiorelli, University of Campania "Luigi Vanvitelli"
Study Sponsor  ICMJE University of Campania "Luigi Vanvitelli"
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfonso Fiorelli, MD, PhD University of Campania "Luigi Vanvitelli"
PRS Account University of Campania "Luigi Vanvitelli"
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP