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Dentofacial DeformitiesPhase 2NCT03974035

Does it Worth to Reinforce With Additional Anesthesia to Improve Postoperative Course After Orthognathic Surgery?

A Phase 2 study testing Second infiltration pre-extubation with ropivacaine in people with Dentofacial Deformities, run by Servei Central d'Anestesiologia at 1 site in Spain.

Completed

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

Official record
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Trial summary

Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field for correction of dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and the etiology is unknown, with genetic, environmental and embryonic factors… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dentofacial Deformities
What is being tested?
Second infiltration pre-extubation with ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
10 Jan 2018to 30 Jan 2020
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients who undergo scheduled bimaxillary surgery

Who cannot join

  • patients who are scheduled for bimaxillary surgery together with another complementary surgical procedure (such as mentoplasty, rhinoplasty, blepharoplasty)
  • age <18 years
  • reinterventions
  • urgent surgeries
  • allergies to local anesthetics
  • allergies to anti-inflammatories agents
  • allergies to opioids
  • American Society of Anesthesiology Physical Status Examination System (ASA) >3

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Centro Medico Teknon - Grupo Quirón Salud

    Barcelona, 08017

Other trials in Spain

About this study

Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field for correction of dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and the etiology is unknown, with genetic, environmental and embryonic factors related. The surgery technic is complex, and requires osteotomy of the maxilla and jaw, which allows toward, forward, impact and rotation of these bones to fix the edges of the face. The anesthetic management of these patients is a challenge because of the difficult airway management and the perioperative pain control. Multimodal approach for pain control is a fact, and the use of local anesthesia is mandatory. The investigators propose the infiltration of local anesthesia in two different times, first pre-incision and second before awaking the patient, for a proper control of postoperative pain

Read the detailed description

Bimaxillary osteotomy is a surgical procedure in the field of orthognathic surgery (from Latin, "ortho" straight and "gnatho" jaw) for the correction of dentofacial deformities, both for functional and aesthetic reasons. The incidence of this deformity is estimated to be around the 5-10% of the population. Genetic, environmental and embryonic factors are postulated to be the origin of such deformity, though its origin is still unknown. The surgical technique is complex, with the performance of mandibular and upper jaw osteotomies that allow to advance, retrude, impact and rotate these bones, to align the facial axes. For all these reasons, the anesthetic management of these patients is a challenge. First, the foreseeable difficulty of managing the patient's airway; and second, the control of the patient's pain in the perioperative period.

Therefore, bimaxillary osteotomy is a frequent surgery and potentially painful in adults. Bimaxillary surgery under general anesthesia is the common practice. And peripheral non-ultrasound-guided peripheral nerve blocks are widely used by surgeons. These minor blockades are used to avoid the undesired effects of anesthetics and analgesics; mainly the adverse respiratory effects of opioids. The practice of loco-regional anesthesia provides a control of perioperative pain in a multimodal way showing effective postoperative analgesia and minimizing the respiratory depression caused by the excess use of opioids.

In general, during bimaxillary surgery the surgeon performs the infiltrations with local anesthetic (LA) in a pre-incisional manner for the blockade of the terminal branches of the maxillary and mandibular nerve intranasally and intraorally. The choice of LA is influenced by considerations such as the start of action, duration and toxicity. A wide range of LA has been used in maxillofacial surgery, such as lidocaine and ropivacaine among others. Both LA produce a reversible blockade of the sodium channel of the neuronal membrane, and are synthetic derivatives of cocaine. Both possess three essential functional units (hydrophilic tertiary amide chain, linked by an intermediate amide chain, to another lipophilic aromatic ring-portion). This means, both LA are amide type; but even if they belong to the same group of LA there is still great differences in the beginning of action, duration of action and toxicity. Lidocaine has a faster start of action (short latency) than ropivacaine, and has an antiarrhythmic effect. Ropivacaine is more potent, the action last longer than lidocaine, has vasoconstrictor effect by itself and is less cardiotoxic than other equipotent LA such as bupivacaine and levobupivacaine.

The investigators avoid the use of a combination of LA for maxillary and mandibular nerve block. The combination of several local anesthetics in the same nerve block is sometimes used in perioperative anesthesia with the intention of compensating the short duration of action of some agents whose start of action is fast, such as lidocaine, and the high latency of the agents that present a more lasting action, such as ropivacaine. The combination of lidocaine and ropivacaine offers clinical advantages (rapid onset, long duration). However, to date, indications for combining LA are scarce because of the use of catheters in many forms of regional anesthesia that allow to prolong the duration of the block. This is nevertheless not an extended practice among anesthesiologists in maxillofacial surgery. On the other hand, it is important to also remember avoiding the use of maximum doses of two LA combined, which is based on the erroneous belief that their toxicities are independent; on the contrary, the toxicities have an additive character.

Multiple drugs have been used to increase the time of action of LA, such as adrenaline, clonidine, dexamethasone, ketamine and dexmedetomidine, among others. In the investigator's patients, adrenaline is always administered along with physiological serum pre-incision by the surgeon at the local level to improve the surgical field. The use of clonidine is ruled out because it is not supplied in the hospital center where the researchers will carry out the study. The use of dexamethasone and ketamine is ruled out, because they will be administered intravenously in the patient's perioperative period as anti-inflammatory agents and anesthetic adjuvant, respectively. And the use of dexmedetomidine is also ruled out in order to prolong the effect of the nerve blockade as this indication is not in the technical file.

Thus, the investigators propose to use firstly lidocaine and adrenaline pre-incision (antiarrhythmic effect and short duration of action). And secondly, they propose to use ropivacaine without adjuvant before extubation (vasoconstrictor effect and longer duration of action).

The control of postoperative pain is a primary factor to achieve greater patient satisfaction, better rehabilitation and shorter hospital stay. The current clinical guidelines recommend the management of postoperative pain control in a multimodal manner; and this includes the use of local anesthetics.

Being tested
Second infiltration pre-extubation with ropivacaine
Keywords
Local anesthesia, Ropivacaine
Medical subject headings
Dentofacial Deformities

What participants receive

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

  • Second infiltration pre-extubation with ropivacaineDrug

    The surgeon will proceed firstly with pre-incisional infiltration with lidocaine and adrenaline after intubation, and secondly with pre-extubation infiltration with ropivacaine at the intraoral and intranasal submucosal level in the maxilla and jaw to block the terminal branches of the maxillary and mandibular nerve

Study groups in NCT03974035
Study groupRoleWhat they receive
Control GroupNo interventionPatients undergoing elective bimaxillary osteotomy who receive a preincisional infiltration of lidocaine and adrenaline.
Study GroupExperimentalPatients undergoing elective bimaxillary osteotomy who receive two infiltrations (firstly pre-incision with lidocaine and adrenaline, secondly pre-extubation with ropivacaine).
Receives: Drug: Second infiltration pre-extubation with ropivacaine

What is being measured

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

  1. Pain assessed by the visual analogue scale (VAS) in the immediate postoperative period

    The main objective of the study is the evaluation of the effect of a peripheral pre-incisional minor nerve block with the use of a single local anesthetic (lidocaine), compared with the same nerve block in two times with different local anesthetics (lidocaine-preincisional and ropivacaine-pre-extubation), on the postoperative pain of patients undergoing elective bimaxillary osteotomy, evaluated by means of the visual analogue scale (VAS) of pain in the immediate postoperative period (2 hours postoperatively).

    The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in centimeters (0 to 10) from the "no pain" anchor point.

    Measured: 2 hours postoperatively

Secondary outcomes (4)
  1. Pain assessed by VAS at 4, 8 and up to 18 hours after surgery.

    The comparison of visual analogue scale (VAS) of pain at 4, 8 and up to 18 hours after surgery.

    The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in centimeters (0 to 10) from the "no pain" anchor point.

    Measured: 4, 8 and up to 18 hours after surgery

  2. Opioid use of rescue (intravenous methadone milligrams)

    The comparison of the opioid use of rescue (intravenous methadone milligrams) in the immediate postoperative period in resuscitation (2 hours postoperatively) and in the hospitalization floor (18 hours postoperatively)

    Measured: 2 and 18 hours postoperatively

  3. Postoperative nausea and vomiting (PONV)

    Comparing the incidence of postoperative nausea and vomiting (PONV) in the immediate postoperative period in resuscitation and up to 18 hours after the surgery in the two groups of patients

    Measured: 2 and 18 hours postoperatively

  4. Complications derived from the two infiltrations

    Registry of complications derived from the two infiltrations

    Measured: Through surgery completion and 0 to 18 hours postoperatively

Timeline

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

  1. First posted4 Jun 2019
  2. Study start10 Jan 2018
  3. Primary completion20 Jan 2020
  4. Study completion30 Jan 2020

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators propose a double-blinded prospective comparative experimental study (patient and nurse). After the approval of the ethics committee of our hospital and the signed consent from each of the patients in the study, patients will be scheduled for bimaxillary osteotomy and will be randomly and prospectively assigned to one of the two groups with a plan to register up to 52 patients. Patients will not know the group that they have been assigned consecutively; and both the postoperative resuscitation nurses and the hospitalization nurses who will perform VAS records, opioid consumption, PONV and postoperative complications, will also be unaware of the analgesic treatment that the patient has received in the operating room. Patients will be assigned randomly to one group or another:
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974035
Sponsor's protocol ID
1TDGM
Status last verified
Feb 2020
First submitted
13 May 2019
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Second infiltration pre-extubation with ropivacaine in people with Dentofacial Deformities, run by Servei Central d'Anestesiologia at 1 site in Spain.

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 8 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 13 Feb 2020. 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 Spain. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pain assessed by the visual analogue scale (VAS) in the immediate postoperative period (time frame: 2 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Feb 2020.

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