Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection

• ClinicalTrials.gov Identifier: NCT00822133
• Recruitment Status: Unknown
• First Posted: January 14, 2009
• Last Update Posted: January 14, 2009
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by: Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: January 13, 2009
• First Posted Date: January 14, 2009
• Last Update Posted Date: January 14, 2009
• Study Start Date: February 2009
• Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 13, 2009): reduce postoeprative pain [ Time Frame: up to 3 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 13, 2009): overall patient satisfaction [ Time Frame: up to 3 months ]
• 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: Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection
• Official Title: Not Provided
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Postoperative Pain

Intervention

• Drug: lidocaine
  lidocaine 5%
• Drug: ketamine
  ketamine cream
• Drug: non-active drug cream
  will be put on the skin

Study Arms

• Active Comparator: lodocaine
  lidocaine 5% cream will be put on the skin
  Intervention: Drug: lidocaine
• Experimental: ketamine
  ketamine 5% will be put on the skin
  Intervention: Drug: ketamine
• Placebo Comparator: placebo
  non-active cream will be put on the skin
  Intervention: Drug: non-active drug cream

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 13, 2009): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2009
• Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• all patients undergoing VAT

Exclusion Criteria:

• emergency patients, open thoracotomy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00822133
• Other Study ID Numbers: 0250-08-TLV
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AA Weinbroum, MD, Tel Aviv Sourasky Medical Center
• Study Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: January 2009