The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

Anesthesia Clinical Trial

Official title:

Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167187
• Other study ID #: FMASU MD94/2023
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: Mohamed Atef, ass.lecturer
• Phone: 00201065270020
• Email: Moahmed.Atef[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Mandibular Fractures

Intervention

Procedure:
• bilateral inferior alveolar nerve block
Placing the tip of the thumb or forefinger into the coronoid notch (retromolar fossa) to help visualize the vertical height at which the needle will enter, and retracting the cheek to expose the pterygomandibular triangle. Placing the barrel of the syringe over the contralateral lower 1st and 2nd premolars and resting the side of the needle tip against the lateral edge of the pterygomandibular raphe, aiming the tip of the needle into the pterygomandibular triangle, with the bevel facing the ramus. Advancing the needle tip slightly into the mucosa until it is stopped by the ramus (typically after about 2 to 2.5 cm of insertion) and withdrawing needle 1 mm away from bone. Aspirating to rule out intravascular placement. If aspiration reveals intravascular placement, withdrawal of the needle will be done 2 to 3 mm, then reaspirating prior to injection. Slowly injecting about 2 to 4 milliliters of bupivacaine 0.5% anesthetic in each side..

Drug:
• Ketorolac and fentanyl
in control group, Patients will not receive the block and pain will be controlled according to institutional protocol using 30 mg ketorolac IV and fentanyl increments as needed.

Locations

Country	Name	City	State
Egypt	Faculty of medicine - Ain shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of the first dose of fentanyl rescue analgesia intraoperative	guided by hemodynamic changes	Throughout the surgery
Primary	Total amount of additional intraoperative fentanyl rescue analgesia	guided by hemodynamic changes	Throughout the surgery
Primary	The time from recovery to the first dose pethidine rescue analgesic	guided by visual analogue scale.	24 hours postoperatively
Primary	Total amount of pethidine postoperative rescue analgesic	guided by visual analogue scale.	24 hours postoperatively
Secondary	Incidence of complications related to the block		24 hours postoperatively