Maxillofacial SurgeryNCT05031676

Opioid Free Anesthesia in Maxillofacial Surgery

A study testing opioid free anesthesia in people with Maxillofacial Surgery, run by Université NAZI BONI at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 65 years
Conditions the study is for: Maxillofacial Surgery
What is being tested?: opioid free anesthesia
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteBurkina Faso
Study dates: 15 Feb 2019to 5 Oct 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Guibla
Bobo-Dioulasso, Houet

Other trials in Burkina Faso

About this study

Official title: 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.

Read the detailed description

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

Conditions: Maxillofacial Surgery
Being tested: opioid free anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

opioid free anesthesiaOther
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.

Study groups in NCT05031676
Study group	Role	What they receive
group 1	Experimental	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. Receives: Other: opioid free anesthesia
group 2	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Highest numerical pain score
The main highest numerical pain score postoperatively
Measured: First two hours postoperatively

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20195 Oct 2020

First posted2 Sep 2021
Study start15 Feb 2019
Primary completion15 Jun 2020
Study completion5 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Maxillofacial SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: The patients were randomized during the pre-anesthetic visit in two groups 1 and 2. They were randomized in blocks of four so that, in each block of four patients, there were two patients for the protocol 1 and two patients for the protocol 2.
Masking: Single blind
Who is masked: Participant
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05031676
Sponsor's protocol ID: INSSA
Status last verified: Aug 2021
First submitted: 7 Aug 2021
Last updated: 2 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Use number and date to find participant folder. Participant data are confidential.

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.
PubMed 28431750
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.
PubMed 28333299
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.
PubMed 24348288
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.
PubMed 30933925
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.
PubMed 25990496
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.
PubMed 31605587

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral

All Maxillofacial Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficiency of Opioid-free Anesthesia (OFA) in Maxillofacial Surgery
ClinicalTrials.gov ID: NCT05031676
Acronym / sponsor ID: INSSA
Conditions: Maxillofacial Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Université NAZI BONIUniversity, hospital or other
Study start: 15 Feb 2019 (actual)
Primary completion: 15 Jun 2020 (actual)
Study completion: 5 Oct 2020 (actual)
First posted: 2 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The patients were randomized during the pre-anesthetic visit in two groups 1 and 2. They were randomized in blocks of four so that, in each block of four patients, there were two patients for the protocol 1 and two patients for the protocol 2.

Arm	Type	Receives
group 1	Experimental	Other: opioid free anesthesiaIntervention 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.
group 2	No intervention	–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.

Who may qualify

Ages: 15 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

Known or suspected coronary artery disease on preoperative consultation;
Unstable arterial hypertension
Insulin-dependent diabetes
Second degree atrioventricular block
Neuro-vegetative dysautonomia;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
opioid free anesthesiaMaintenance 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.	Other	group 1

Primary outcome

Highest numerical pain score
Time frame: First two hours postoperatively
The main highest numerical pain score postoperatively

7 secondary outcomes

Blood pressure
Time frame: six minutes after incision
Ephedrine
Time frame: During anesthesia
Wake up
Time frame: Time between the end of surgery and extubation
Nausea-Vomiting
Time frame: During 24 after surgery
Highest numerical pain score 24 hours
Time frame: The first 24 hours postoperatively
Non-surgical complications
Time frame: During 24 hours after surgery
Heart rate
Time frame: six minutes after incision

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Results publicationDe Kock M. L'anesthésie sans opiacés : anecdote ou nécessité ? Douleur et Analgésie. 2014 sept;27(3):145-148.
Results publicationBeloeil H. Anesthésie sans opiacés. Anesth Réanimation. 2018 may;4(3):215-218.
Results publication: PubMed 28431750Mulier 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.
Results publication: PubMed 28333299Parsa 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.
Results publication: PubMed 24348288Mansour 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.
Results publication: PubMed 30933925Soffin 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.
Results publication: PubMed 25990496Bakan 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.
Results publication: PubMed 31605587Toleska 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.
Individual participant dataSharing planned: No. Use number and date to find participant folder. Participant data are confidential.

Related trials for Maxillofacial Surgery

Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ismael Guibla, Doctor principal investigator

University Hospital Souro Sanou, Burkina Faso

Charles Ilboudo, Doctor study chair

University Hospital Souro Sanou, Burkina Faso

Bertille Ki, Professor study chair

Univesity of Joseph KI-ZERBO, Health sciences institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing opioid free anesthesia in people with Maxillofacial Surgery, run by Université NAZI BONI at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Highest numerical pain score (time frame: First two hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05031676, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.