Clinical trial NCT06167187: The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries
Official title: Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.

Detailed description: Opioid drug administration is a common technique to reduce pain from surgical trauma. However, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus.

In maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. Ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. Various methods have been proposed to minimize these side effects. Nerve block with long-acting local anesthesia is a proposed technique in this regard.

In maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac.

Inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. It can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity.

The inferior alveolar nerve (IAN) block is a widely used regional anaesthetic nerve block for the mandible. The most commonly used technique for IAN block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. Once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.

Eligibility criteria: Inclusion Criteria:

1. Age group: 18 - 65 years old.
2. American Society of Anesthesiologists (ASA) Physical Status Class I to III
3. Scheduled for fracture mandible fixation.

Exclusion Criteria:

1. Refusing to participate in the study.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including coagulopathy and local infection).
4. Psychiatric disorders.
5. Pregnancy.

Primary outcomes:
measure: The time of the first dose of fentanyl rescue analgesia intraoperative
timeFrame: Throughout the surgery
measure: Total amount of additional intraoperative fentanyl rescue analgesia
timeFrame: Throughout the surgery
measure: The time from recovery to the first dose pethidine rescue analgesic
timeFrame: 24 hours postoperatively
measure: Total amount of pethidine postoperative rescue analgesic
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Incidence of complications related to the block
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine - Ain shams university hospitals
Study officials:
affiliation: faculty of medicine, ain shams university
name: Mohamed Atef, ass.lecturer
role: PRINCIPAL_INVESTIGATOR
References: