Clinical Trial: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

Brief Summary: Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.

Detailed Summary:

Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.

All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).

Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department


Sponsor: Western Galilee Hospital-Nahariya

Current Primary Outcome:

  • Pain: reduction in severity based on VAS score. [ Time Frame: the morning of first post operative day ]
    The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day
  • consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively. [ Time Frame: the morning of first post operative day ]
    The data will be collected from the medical file


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Readmission for any reason. [ Time Frame: one week ]
  • Duration of hospital stay. [ Time Frame: one week ]


Original Secondary Outcome: Same as current

Information By: Western Galilee Hospital-Nahariya

Dates:
Date Received: November 14, 2014
Date Started: April 2015
Date Completion: December 2017
Last Updated: November 14, 2016
Last Verified: November 2016