Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
lidocaine
ketamine
non-active drug cream
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring ketamine, preemption, postoperative, pain, safety
Eligibility Criteria
Inclusion Criteria:
- all patients undergoing VAT
Exclusion Criteria:
- emergency patients, open thoracotomy
Sites / Locations
- Tel Aviv Sourasky Medical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
lodocaine
ketamine
placebo
Arm Description
lidocaine 5% cream will be put on the skin
ketamine 5% will be put on the skin
non-active cream will be put on the skin
Outcomes
Primary Outcome Measures
reduce postoeprative pain
Secondary Outcome Measures
overall patient satisfaction
Full Information
NCT ID
NCT00822133
First Posted
January 13, 2009
Last Updated
January 13, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00822133
Brief Title
Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since VAT bears with it severe postopearive pain, and since ketamine has been shown to be an optimal analgesics adjuvant for postoperative pain, we wish to assess to effects of ketamie vs. lidocaine if put on the skin in the sites where scopes are interset into the chest for thoracoscopy.
Detailed Description
Ketamine hydrochlorid is a general anesthetic that is also used as short term sedative. Ketamine has an antagonistic effect on the central spinal N-Methyl-D-Aspartate (NMDA) receptors, the latter modulating pain stimuli generated peripherally on their way to central pain centers.
Ketamine has been used recently pre-operatively rather than post-operatively. Our recent experience with pre-operative use of ketamine has not been analyzed yet by Tel Aviv Medical Center's researchers. However, there is some experience with topical dermal, epidural, intra-articular and oral usage of ketamine.
As far as we no, there are no reports on patients' subjective feeling when ketamine was given pre-operatively for postoperative acute pain in patients undergoing partial lung resections. The possible influence of such an effect on the patient's well-being and the patient's family feelings and reactions were neither explored.
The goal of the study is to examine the possibility that if ketamine is administered in the pre-operative period, as a topical ointment, this will induce changes in the patient's sensation of pain, his own satisfaction, and possibly his family's satisfaction as well. The basis of this contention is that by administering less morphine (which is given to the patient in the immediate post-operative period through PCA [Patient-Controlled Analgesia]), with or without changes in pain, might have positive effects on the patient's well being and his family's. This issue will be assessed by a verbal questionnaire and based and on a visual analog scale (VAS).
Three groups of 20 patients each will be enrolled in the study. The first group will receive a placebo topical paste which will be produced by the hospital pharmacy. The second group will be given Lignocain paste, and the third group will get ketamine topical paste, prepared by the pharmacy as well. The study will be double blind and randomized. All patients will be treated with morphine postoperatively, as mentioned above.
It is anticipated that the amounts of morphine that will be used by the patients postoperatively by patients treated by ketamine will be reduced as compared to the other groups. This might increase the patient's and family's satisfaction rates, regardless of the decrease in the subjective pain ratings.
The importance of this study is that if the contention that is at the basis of this study is proven true, similar surgical groups of patients will benefit from the addition of topical ketamine administration to the habitual morphine-used postoperative only analgesia. By doing so, complications that stem from high doses of morphine will diminish, thus maintain hemodynamic stability and benefiting from the advantages of a patient being awake, cooperative and able to feedback the medical personnel in real time about his condition. Cooperation and satisfaction of the patient and family could be the end result of this process. Finally, it is assumed that under such conditions the number of complications in the postoperative period will minimize as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ketamine, preemption, postoperative, pain, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lodocaine
Arm Type
Active Comparator
Arm Description
lidocaine 5% cream will be put on the skin
Arm Title
ketamine
Arm Type
Experimental
Arm Description
ketamine 5% will be put on the skin
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
non-active cream will be put on the skin
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
lidocaine 5%
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
ketamine cream
Intervention Type
Drug
Intervention Name(s)
non-active drug cream
Intervention Description
will be put on the skin
Primary Outcome Measure Information:
Title
reduce postoeprative pain
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
overall patient satisfaction
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients undergoing VAT
Exclusion Criteria:
emergency patients, open thoracotomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi A Weinbroum, MD
Phone
972-3-697-3237
Email
draviw@tasmc.health.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky Medical center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi A Weinbroum, MD
Phone
972-3-697-3237
Email
draviw@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Avi A Weinbroum, MD
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection
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