Opioid Free Anesthesia and Major Spine Surgery

Lebanese American University

Status: Completed

Conditions: Postoperative Pain; Spine Disease; Opioid Use

Treatments: Drug: opioid free Anesthesia vs Opioid based Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03417193

LAUMCRH.HB1.11/Jan/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Opioid based Anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: opioid free Anesthesia vs Opioid based Anesthesia

Opioid Free Anesthesia

Active Comparator group

Description:

-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.

Treatment:

Drug: opioid free Anesthesia vs Opioid based Anesthesia