Percutaneous Ketamine Versus Lidocaine for Mid-Sternotomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00822419
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

Since midsternotomy is painful postoepratively, and since ketamine has been shown to be optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous preemptive effect, comparing it to lidocaine effect.


Condition Intervention Phase
Sternotomy
Drug: lidocaine
Drug: ketamine
Drug: non-drug cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Reduced postoperative pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: February 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lidocaine
Lidocaine 5% cream 5 gr will be double blindly put on the skin preoperatively
Drug: lidocaine
lidocaine cream 5%
Experimental: ketamine
ketamine cream 5% 5gr will be put on the skin preoperatively
Drug: ketamine
ketamine 5%
Sham Comparator: placebo
non-drug similar cream will be put on the skin preoperatively
Drug: non-drug cream
will be put on the skin

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.

Ketamin 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. There is also 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 mid-sternotomy for lung and cardiac surgery. 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 [Patent-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 25 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, and hasten rehablitation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing sternoromy for cardiac or chest sturgery

Exclusion Criteria:

  • emergency surgery
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822419

Contacts
Contact: Avi A Weinbroum, MD 972-3-697-3237 draviw@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Avi A Weinbroum, MD    972-3-697-3237    draviw@tasmc.health.gov.il   
Principal Investigator: Avi A Weinbroum, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: AA Weinbroum, MD, Tel AvivSourasky Medical Center
ClinicalTrials.gov Identifier: NCT00822419     History of Changes
Other Study ID Numbers: 0251-08-TLV
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: Israel: TASMC Monitoring Comittee

Keywords provided by Tel-Aviv Sourasky Medical Center:
sternotomy pain

Additional relevant MeSH terms:
Ketamine
Lidocaine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 29, 2014