The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

NCT ID: NCT06167187

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-30

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group (IAN block group)

patients will receive bilateral inferior alveolar nerve block. 23 patients

Group Type: ACTIVE_COMPARATOR

bilateral inferior alveolar nerve block

Intervention Type: PROCEDURE

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..

control group

patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol.

23 patients

Group Type: ACTIVE_COMPARATOR

Ketorolac and fentanyl

Intervention Type: DRUG

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.

Interventions

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..

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

IANB

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

mohamed atef

assistant lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Atef, ass.lecturer

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine, ain shams university

Locations

Faculty of medicine - Ain shams university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Atef, ass.lecturer

Role: CONTACT

Phone: 00201065270020

Email: Moahmed.Atef@med.asu.edu.eg

Facility Contacts

Mohamed Atef, Ass.lecturer

Role: primary

Other Identifiers

FMASU MD94/2023

Identifier Type: -

Identifier Source: org_study_id