Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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"

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.

Condition or disease Intervention/treatment Phase
Post Thoracotomy Pain Drug: Ketamine Drug: Normal Saline Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Official Title: 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.
Actual Study Start Date : January 5, 2012
Actual Primary Completion Date : December 21, 2014
Actual Study Completion Date : February 1, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine Group
Five minutes before thoracotomy incision, Ketamine Group received a bolus dose of ketamine 1 mg/kg intravenously
Drug: Ketamine
A bolus dose of ketamine 1 mg/kg intravenously five minutes before surgical incision

Placebo Comparator: Placebo Group
Five minutes before thoracotomy incision, Placebo Group received a bolus dose of normal saline 1 mg/kg intravenously
Drug: Normal Saline
A bolus dose of normal saline 1 mg/kg intravenously five minutes before surgical incision




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03415191


Locations
Layout table for location information
Italy
Alfonso Fiorelli
Naples, Italy, 84100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Layout table for investigator information
Principal Investigator: Alfonso Fiorelli, MD, PhD University of Campania "Luigi Vanvitelli"

Publications:

Layout table for additonal information
Responsible Party: Alfonso Fiorelli, Assistant Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03415191     History of Changes
Other Study ID Numbers: 513/12
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfonso Fiorelli, University of Campania "Luigi Vanvitelli":
ketamine, post-thoracotomy pain, analgesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action