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Opioid Free Anesthesia and Major Spine Surgery

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ClinicalTrials.gov Identifier: NCT03417193
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hanane Barakat, Lebanese American University

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE January 31, 2018
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE January 29, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Postoperative pain score [ Time Frame: 48 hours post operative. ]
Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours to be repeated every 6 hours thereafter up to 48 hours post surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Postoperative morphine consumption [ Time Frame: 48 hours ]
    After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery.. And the total amount of morphine in mg will be calculated for 48 hours
  • Postoperative morphine Side effects: Sedation score . [ Time Frame: 48 hours post operative. ]
    -Sedation score: 0 alert
    1. Mild, drowsy , easy to awake
    2. moderate, easy to arouse
    3. Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
  • Postoperative morphine Side effects:Respiratory depression [ Time Frame: 48 hours ]
    Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute. The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
  • Postoperative morphine Side effects: Nausea vomiting [ Time Frame: 48 hours ]
    Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting. The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
  • Postoperative morphine Side effects: Itching [ Time Frame: 48 hours ]
    Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Free Anesthesia and Major Spine Surgery
Official Title  ICMJE Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
Brief Summary This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
Detailed Description

Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects.

Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Use
  • Postoperative Pain
  • Spine Disease
Intervention  ICMJE Drug: opioid free Anesthesia vs Opioid based Anesthesia
Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.
Study Arms  ICMJE
  • Active Comparator: Opioid based Anesthesia
    General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.
    Intervention: Drug: opioid free Anesthesia vs Opioid based Anesthesia
  • Active Comparator: Opioid Free Anesthesia
    -General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.
    Intervention: Drug: opioid free Anesthesia vs Opioid based Anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age group: 18-80 years old
  • American Society of Anesthesiologists (ASA )class I, II and III
  • Elective spine posterior instrumentation surgery of at least two levels.

Exclusion Criteria:

  • Renal, hepatic or cardiac insufficiency.
  • Alcohol or drug abuse.
  • Psychiatric disease.
  • Allergy or contraindication to any of the study drugs.
  • Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hanane Barakat, MD +9611200800 ext 5168 hanane.barakat@lau.edu.lb
Contact: Vanda Abi Raad, MD +9611200800 ext 5168 vanda.abiraad@lau.edu.lb
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03417193
Other Study ID Numbers  ICMJE LAUMCRH.HB1.11/Jan/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hanane Barakat, Lebanese American University
Study Sponsor  ICMJE Lebanese American University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hanane MD Lebanese American University/ LAU Medical Center
PRS Account Lebanese American University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP