Opioid Free Anesthesia in Maxillofacial Surgery

Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery

Opioid free anesthesia is a promising practice in anesthesia. Studies already carried out have compared OFA to an opioid or "opioid anesthesia" (OA) protocol without the use of antihyperalgesic in the OA protocol. Most of the studies currently available have been carried out in Europe, America and a few in Asia under conditions other than those available in precarious situations.That's why we decide to conduct a study to evaluate the effectiveness of an OFA protocol in maxillofacial surgery in Burkina Faso.

Study Overview

• Status: Completed
• Conditions: Maxillofacial Surgery
• Intervention / Treatment: Other: opioid free anesthesia

Detailed Description

The patients were recruited at the University Hospital of Souro Sanou in Bobo Dioulasso

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Houet
    • Bobo-Dioulasso, Houet, Burkina Faso
      • Guibla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients aged between 15 and 65 years, admitted to the central operating room of the hospital for maxillofacial surgery.

Exclusion Criteria:

• Known or suspected coronary artery disease on preoperative consultation;
• Unstable arterial hypertension
• Insulin-dependent diabetes
• Second degree atrioventricular block
• Neuro-vegetative dysautonomia;
• known allergy or intolerance to a drug of the protocols

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; Intervention consists at induction : direct intravenous lidocaine 1.5 mg/kg; clonidine 2 μg/kg in 250 ml of isotonic saline, started as soon as the venous route is taken and over a period of approximately 15 minutes; magnesium sulfate 50 mg/kg in the same isotonic saline as clonidine.	Other: opioid free anesthesia; Maintenance of anesthesia was done with halothane. The incision was allowed at 1.2 MAC of halothane. This halogen was administered according to the hemodynamic parameters and the habits of the anesthesia team. Before waking up, all the patients benefited from preventive analgesia with 1 g paracetamol combined with 20 mg nefopam by slow intravenous injection over approximately 15 minutes.
No Intervention: group 2; In classic induction: fentanyl at a dose of 2 µg/kg. Following induction in all patients consisted of the administration of propofol 2-3 mg/kg in titration, rocuronium 0.6 mg/kg, ketamine 0.5 mg/kg, methylprednisolone 120 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest numerical pain score	The main highest numerical pain score postoperatively	First two hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Changes in blood pressure	six minutes after incision
Ephedrine	Intraoperative consumption of ephedrine	During anesthesia
Wake up	wake up time	Time between the end of surgery and extubation
Nausea-Vomiting	The proportion of nausea-vomiting after surgery	During 24 after surgery
Highest numerical pain score 24 hours	The mean of the highest EN score during the first 24 hours postoperatively	The first 24 hours postoperatively
Non-surgical complications	The proportion of non-surgical complications within 24 hours of anesthesia	During 24 hours after surgery
Heart rate	Changes in heart rate	six minutes after incision

Collaborators and Investigators

• Sponsor: Université NAZI BONI
• Investigators: Principal Investigator: Ismael Guibla, Doctor, University Hospital Souro Sanou, Burkina Faso; Study Chair: Charles Ilboudo, Doctor, University Hospital Souro Sanou, Burkina Faso; Study Chair: Bertille Ki, Professor, Univesity of Joseph KI-ZERBO, Health sciences institute; Study Chair: Jean Paul Lechat, Doctor, Hospital of Charleroi (GHdC), Belgium; Study Chair: Cheick Bougouma, Doctor, Univesity of Joseph KI-ZERBO, Health sciences institute; Study Director: Alain Traore, Professor, University of Nazi Boni, Health sciences institute; Study Director: Flavien Kabore, Professor, Univesity of Joseph KI-ZERBO, Health sciences institute

Publications and helpful links

General Publications

• De Kock M. L'anesthésie sans opiacés : anecdote ou nécessité ? Douleur et Analgésie. 2014 sept;27(3):145-148.
• Beloeil H. Anesthésie sans opiacés. Anesth Réanimation. 2018 may;4(3):215-218.
• Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish.
• Parsa FD, Cheng J, Stephan B, Castel N, Kim L, Murariu D, Parsa AA. Bilateral Breast Reduction Without Opioid Analgesics: A Comparative Study. Aesthet Surg J. 2017 Sep 1;37(8):892-899. doi: 10.1093/asj/sjx038.
• Mansour MA, Mahmoud AA, Geddawy M. Nonopioid versus opioid based general anesthesia technique for bariatric surgery: A randomized double-blind study. Saudi J Anaesth. 2013 Oct;7(4):387-91. doi: 10.4103/1658-354X.121045.
• Soffin EM, Wetmore DS, Beckman JD, Sheha ED, Vaishnav AS, Albert TJ, Gang CH, Qureshi SA. Opioid-free anesthesia within an enhanced recovery after surgery pathway for minimally invasive lumbar spine surgery: a retrospective matched cohort study. Neurosurg Focus. 2019 Apr 1;46(4):E8. doi: 10.3171/2019.1.FOCUS18645.
• Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. [Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study]. Rev Bras Anestesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjan.2014.05.006. Epub 2014 Nov 1. Portuguese.
• Toleska M, Dimitrovski A. Is Opioid-Free General Anesthesia More Superior for Postoperative Pain Versus Opioid General Anesthesia in Laparoscopic Cholecystectomy? Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2019 Oct 1;40(2):81-87. doi: 10.2478/prilozi-2019-0018.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: INSSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Use number and date to find participant folder. Participant data are confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No