Dentofacial DeformitiesNCT03913429
Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy
A study testing Infiltration and Maxillary nerve blockade in people with Dentofacial Deformities and Regional Anesthesia Morbidity, run by Servei Central d'Anestesiologia at 1 site in Spain.
Trial summary
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field with the aim to correct dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and its etiology is unknown, with genetic, environmental and embryonic factors… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities, Regional Anesthesia Morbidity
- What is being tested?
- Infiltration and Maxillary nerve blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2018to 30 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who undergo scheduled bimaxillary surgery
Who cannot join
- the refusal to participate in the study,
- 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,
Show all 9Show fewer
- allergies to anti-inflammatories agents,
- allergies to opioids,
- American Society of Anesthesiologists Physical Status Classification (ASA) ≥3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block on Postoperative Pain After Elective Bimaxillary Osteotomy in Adult Patients
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field with the aim to correct dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and its etiology is unknown, with genetic, environmental and embryonic factors related. The surgical technique is complex, and requires osteotomy of the maxillary 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 and regional anesthesia is mandatory. The investigators propose bilateral suprazygomatic maxillary nerve block for a proper control of postoperative pain after bimaxillary osteotomy.
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 nerve intraorally and intranasally. 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 LAs 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, and is less cardiotoxic than other equipotent LA such as bupivacaine and levobupivacaine.
Subsequently, the introduction of loco-regional nerve blocks has meant for the anesthesiologist, in the last three decades, a revolution in the management and control of perioperative pain. The expansion of the practice of loco-regional nerve blocks has been seen in both upper and lower limbs, as well as in trunk and abdomen. On the contrary, the facial blockages (both superficial and deep) have not experienced the same; laying its practice to the surgeon, or to anesthesiologists working on the chronic pain domain. The subsequent introduction of ultrasonography (USG) in the 1990s in the perioperative period also represented an important advance for anesthesiologist both in terms of safety and in terms of ease of management of venous and arterial catheterizations, and practice of loco-regional blockages. Consequently, USG experienced anesthesiologists have recently published in regards to the use of ultrasounds (US) for the blockage of facial nerves in children and adults undergoing maxillofacial surgery. USG devices are increasingly accessible, more portable, cheaper and safer; and therefore, its introduction in the field of perioperative pain management of maxillofacial surgery has still a long way to go.
The maxillary nerve, just like the ophthalmic, is only sensitive. It is detached from the anterolateral border of the trigeminal ganglion, laterally to the ophthalmic. From its origin, it goes above, crosses the foramen rotundum and penetrates into the background of the infratemporal fossa until it enters the pterygopalatine fossa (except the middle meningeal nerve, all its branches reach the pterygopalatine fossa before reaching the facies). In the pterygopalatine fossa the maxillary nerve is located in the upper part of the cavity and passes superiorly to the maxillary artery and superolaterally to the pterygopalatine ganglion. The maxillary nerve receives and conducts the sensitivity of the skin of the cheek, the lower eyelid, the wing of the nose and the upper lip. Its deep branches drive the sensitivity of the mucosa of the lower part of the nasal cavities or respiratory area, and of the dental roots and the gums of the maxilla.
Therefore, in order to produce an effective anesthesia of the maxillary area, the needle can be introduced through the pterygomaxillary fissure to the pterygopalatine fossa, with risk of vascular and nerve puncture. However, with real-time vision of the ultrasound-guided block, these risks will be limited, allowing a direct localization of the maxillary artery, position of the needle and the distribution of LA within the pterygopalatine fossa. The pterygopalatine fossa is anatomically deep and surrounded by bones. The most optimal ultrasound window is the infrazygomatic path, allowing the visualization of the entire axis of the pterygopalatine fossa up to the foramen rotundum.
The usual practice for the ultrasound-guided maxillary nerve block is the placement of the ultrasound probe in an infrazygomatic position and the introduction of the needle by suprazygomatic route for better visualization of the procedure. The approach by suprazygomatic route from the frontozygomatic angle is one of the safest and recommended routes to reach the foramen rotundum. This trajectory limits the insertion of the needle in the anterior portion of the foramen rotundum, avoiding, this way, the inadvertent puncture of the intraorbital content through the infraorbital fissure.
Experienced anesthesiologists in anesthesia for maxillofacial surgery, perform bilateral ultrasound-guided blockade of the maxillary nerve by suprazygomatic route with ropivacaine for greater control of perioperative pain. These investigators avoid the use of a combination of LA for maxillary 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. To the study patients, adrenaline is always administered along with physiological serum by the surgeon at the local level to improve the surgical field, both in patients who undergo pre-incision infiltration and bilateral blockade of the maxillary nerve. The use of Clonidine is ruled out because it is not supplied in the hospital center where the investigators 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.
- Being tested
- Infiltration, Maxillary nerve blockade
- Keywords
- Orthognathic Surgery, Maxillary nerve blockade
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfiltrationProcedure or surgery
Also called Infiltration in the maxilla
Infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision.
A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml
Maxillary nerve blockadeProcedure or surgery
Also called Ultrasound guided Maxillary nerve blockade
Bilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist.
A total of 5ml of Ropivacaine 0.37% infiltrated on each side. Together with adrenaline infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla.
A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 110ml SF.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision.
A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml. Receives: Procedure: Infiltration |
| Study Group | Experimental | Bilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist.
A total of 5ml of Ropivacaine 0.37% infiltrated on each side. Receives: Procedure: Maxillary nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption
evaluation of the effectiveness of the bilateral ultrasound-guided blockade with ropivacaine by suprazygomatic route, compared to the peripheral infiltration of the nerve with lidocaine and adrenaline, on the consumption of opioids for control of perioperative pain of patients intervened of elective bimaxillary osteotomy, evaluated by means of the analogical visual scale of pain in the immediate postoperative period (2 hours postoperatively).
Measured: 2hours postoperatively
comparison of the use of opioids in the intraoperative period
comparison of the use of opioids in the intraoperative period (Target Controlled Infusion (TCI) ng / ml - intravenous remifentanil),
Measured: intraoperatively
Secondary outcomes (3)
comparison of the use of rescue opioids in the postoperative period in hospitalization
comparison of the use of rescue opioids (milligrams of intravenous methadone) in the postoperative period in hospitalization (2-18hours postoperative)
Measured: (2-18hours postoperative)
the comparison of the incidence of immediate postoperative nausea and vomiting (PONV)
the comparison of the incidence of immediate postoperative nausea and vomiting (PONV) in resuscitation and up to 18 hours after surgery
Measured: 0-18hours after surgery
registry of complications derived from ultrasound-guided maxillary nerve block.
registry of complications derived from ultrasound-guided maxillary nerve block.
Measured: 0-18hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start20 Sep 2018
- Primary completion20 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentofacial DeformitiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servei Central d'Anestesiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria Molins, Principal investigator, Anesthesiologist- Anestalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913429
- Sponsor's protocol ID
- SCAnestalia
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2019
- Last updated
- 17 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
Publications
Molins G, Valls-Ontanon A, De Nadal M, Hernandez-Alfaro F. Ultrasound-Guided Suprazygomatic Maxillary Nerve Block Is Effective in Reducing Postoperative Opioid Use Following Bimaxillary Osteotomy. J Oral Maxillofac Surg. 2024 Apr;82(4):412-421. doi: 10.1016/j.joms.2023.12.018. Epub 2024 Jan 2.
PubMed 38253318
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block on Postoperative Pain After Elective Bimaxillary Osteotomy in Adult Patients
- ClinicalTrials.gov ID
- NCT03913429
- Acronym / sponsor ID
- SCAnestalia
- Keywords
- Orthognathic Surgery, Maxillary nerve blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Servei Central d'AnestesiologiaUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Apr 2019 (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.
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field with the aim to correct dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and its etiology is unknown, with genetic, environmental and embryonic factors related. The surgical technique is complex, and requires osteotomy of the maxillary 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 and regional anesthesia is mandatory. The investigators propose bilateral suprazygomatic maxillary nerve block for a proper control of postoperative pain after bimaxillary osteotomy.
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 nerve intraorally and intranasally. 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 LAs 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, and is less cardiotoxic than other equipotent LA such as bupivacaine and levobupivacaine.
Subsequently, the introduction of loco-regional nerve blocks has meant for the anesthesiologist, in the last three decades, a revolution in the management and control of perioperative pain. The expansion of the practice of loco-regional nerve blocks has been seen in both upper and lower limbs, as well as in trunk and abdomen. On the contrary, the facial blockages (both superficial and deep) have not experienced the same; laying its practice to the surgeon, or to anesthesiologists working on the chronic pain domain. The subsequent introduction of ultrasonography (USG) in the 1990s in the perioperative period also represented an important advance for anesthesiologist both in terms of safety and in terms of ease of management of venous and arterial catheterizations, and practice of loco-regional blockages. Consequently, USG experienced anesthesiologists have recently published in regards to the use of ultrasounds (US) for the blockage of facial nerves in children and adults undergoing maxillofacial surgery. USG devices are increasingly accessible, more portable, cheaper and safer; and therefore, its introduction in the field of perioperative pain management of maxillofacial surgery has still a long way to go.
The maxillary nerve, just like the ophthalmic, is only sensitive. It is detached from the anterolateral border of the trigeminal ganglion, laterally to the ophthalmic. From its origin, it goes above, crosses the foramen rotundum and penetrates into the background of the infratemporal fossa until it enters the pterygopalatine fossa (except the middle meningeal nerve, all its branches reach the pterygopalatine fossa before reaching the facies). In the pterygopalatine fossa the maxillary nerve is located in the upper part of the cavity and passes superiorly to the maxillary artery and superolaterally to the pterygopalatine ganglion. The maxillary nerve receives and conducts the sensitivity of the skin of the cheek, the lower eyelid, the wing of the nose and the upper lip. Its deep branches drive the sensitivity of the mucosa of the lower part of the nasal cavities or respiratory area, and of the dental roots and the gums of the maxilla.
Therefore, in order to produce an effective anesthesia of the maxillary area, the needle can be introduced through the pterygomaxillary fissure to the pterygopalatine fossa, with risk of vascular and nerve puncture. However, with real-time vision of the ultrasound-guided block, these risks will be limited, allowing a direct localization of the maxillary artery, position of the needle and the distribution of LA within the pterygopalatine fossa. The pterygopalatine fossa is anatomically deep and surrounded by bones. The most optimal ultrasound window is the infrazygomatic path, allowing the visualization of the entire axis of the pterygopalatine fossa up to the foramen rotundum.
The usual practice for the ultrasound-guided maxillary nerve block is the placement of the ultrasound probe in an infrazygomatic position and the introduction of the needle by suprazygomatic route for better visualization of the procedure. The approach by suprazygomatic route from the frontozygomatic angle is one of the safest and recommended routes to reach the foramen rotundum. This trajectory limits the insertion of the needle in the anterior portion of the foramen rotundum, avoiding, this way, the inadvertent puncture of the intraorbital content through the infraorbital fissure.
Experienced anesthesiologists in anesthesia for maxillofacial surgery, perform bilateral ultrasound-guided blockade of the maxillary nerve by suprazygomatic route with ropivacaine for greater control of perioperative pain. These investigators avoid the use of a combination of LA for maxillary 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. To the study patients, adrenaline is always administered along with physiological serum by the surgeon at the local level to improve the surgical field, both in patients who undergo pre-incision infiltration and bilateral blockade of the maxillary nerve. The use of Clonidine is ruled out because it is not supplied in the hospital center where the investigators 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: InfiltrationInfiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision. A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml. |
| Study Group | Experimental | Procedure: Maxillary nerve blockadeBilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist. A total of 5ml of Ropivacaine 0.37% infiltrated on each side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who undergo scheduled bimaxillary surgery
Key exclusion criteria (9 listed)
- the refusal to participate in the study,
- patients who are scheduled for bimaxillary surgery together with another complementary surgical procedure (such as mentoplasty, rhinoplasty, blepharoplasty),
- age <18 years,
- reinterventions,
- urgent surgeries,
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 |
|---|---|---|
| InfiltrationAlso: Infiltration in the maxillaInfiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision. A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml | Procedure or surgery | Control Group |
| Maxillary nerve blockadeAlso: Ultrasound guided Maxillary nerve blockadeBilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist. A total of 5ml of Ropivacaine 0.37% infiltrated on each side. Together with adrenaline infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla. A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 110ml SF. | Procedure or surgery | Study Group |
Primary outcome
Opioids consumption
Time frame: 2hours postoperatively
evaluation of the effectiveness of the bilateral ultrasound-guided blockade with ropivacaine by suprazygomatic route, compared to the peripheral infiltration of the nerve with lidocaine and adrenaline, on the consumption of opioids for control of perioperative pain of patients intervened of elective bimaxillary osteotomy, evaluated by means of the analogical visual scale of pain in the immediate postoperative period (2 hours postoperatively).
comparison of the use of opioids in the intraoperative period
Time frame: intraoperatively
comparison of the use of opioids in the intraoperative period (Target Controlled Infusion (TCI) ng / ml - intravenous remifentanil),
3 secondary outcomes
comparison of the use of rescue opioids in the postoperative period in hospitalization
Time frame: (2-18hours postoperative)
the comparison of the incidence of immediate postoperative nausea and vomiting (PONV)
Time frame: 0-18hours after surgery
registry of complications derived from ultrasound-guided maxillary nerve block.
Time frame: 0-18hours after surgery
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 17 Feb 2020.
- Derived from this study: PubMed 38253318Molins G, Valls-Ontanon A, De Nadal M, Hernandez-Alfaro F. Ultrasound-Guided Suprazygomatic Maxillary Nerve Block Is Effective in Reducing Postoperative Opioid Use Following Bimaxillary Osteotomy. J Oral Maxillofac Surg. 2024 Apr;82(4):412-421. doi: 10.1016/j.joms.2023.12.018. Epub 2024 Jan 2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Gloria Molins principal investigator
Anesthesiologist- Anestalia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration and Maxillary nerve blockade in people with Dentofacial Deformities and Regional Anesthesia Morbidity, 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 9 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 17 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.
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?
Opioids consumption (time frame: 2hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT03913429, which also lists 1 linked publication.
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 17 Feb 2020.