The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Procedure: bilateral inferior alveolar nerve block; Drug: Ketorolac and fentanyl

• Registration Number: NCT06167187
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-09
• Last Update Submitted: 2023-12-09
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (IAN block group)	bilateral inferior alveolar nerve block	patients will receive bilateral inferior alveolar nerve block. 23 patients
control group	Ketorolac and fentanyl	patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol. 23 patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of complications related to the block	24 hours postoperatively

Trial Locations

Locations (1)

Faculty of medicine - Ain shams university hospitals; 🇪🇬 Cairo, Egypt