Skip to main content
OpenTrials
Completed

NCT Number: NCT03417193

Opioid Free Anesthesia and Major Spine Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Spinal Diseases Spine Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAU Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

opioid free Anesthesia vs Opioid based Anesthesia

Drug

Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative morphine Side effects: Sedation score .

    Time frame: 48 hours post operative.

    -Sedation score: 0 alert

    • Mild, drowsy , easy to awake
    • moderate, easy to arouse
    • 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Lebanese American University

Other

Registry information

Official study title

Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.