Opioid Free Anesthesia and Major Spine Surgery

NCT ID: NCT03417193

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2023-02-16

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.

Conditions

Opioid Use; Postoperative Pain; Spine Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

opioid free Anesthesia vs Opioid based Anesthesia

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

opioid free Anesthesia vs Opioid based Anesthesia

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lebanese American University

OTHER

Sponsor Role: lead

Responsible Party

Hanane Barakat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanane MD

Role: PRINCIPAL_INVESTIGATOR

Lebanese American University/ LAU Medical Center

Locations

LAU Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

LAUMCRH.HB1.11/Jan/2018

Identifier Type: -

Identifier Source: org_study_id