The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: bilateral inferior alveolar nerve block; Drug: Ketorolac and fentanyl

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Atef, ass.lecturer; Phone Number: 00201065270020; Email: Moahmed.Atef@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Faculty of medicine - Ain shams university hospitals
    • Contact: Mohamed Atef, Ass.lecturer; Phone Number: +201065270020; Email: Moahmed.Atef@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group (IAN block group); patients will receive bilateral inferior alveolar nerve block. 23 patients	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..; Other Names: IANB
Active Comparator: control group; patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol. 23 patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of the first dose of fentanyl rescue analgesia intraoperative	guided by hemodynamic changes	Throughout the surgery
Total amount of additional intraoperative fentanyl rescue analgesia	guided by hemodynamic changes	Throughout the surgery
The time from recovery to the first dose pethidine rescue analgesic	guided by visual analogue scale.	24 hours postoperatively
Total amount of pethidine postoperative rescue analgesic	guided by visual analogue scale.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of complications related to the block	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed Atef, ass.lecturer, Faculty of medicine, Ain Shams university

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 9, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Ketorolac
• Other Study ID Numbers: FMASU MD94/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No