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Clinical Trials/NCT06167187
NCT06167187
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country46 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
bilateral inferior alveolar nerve block
Conditions
Anesthesia
Sponsor
Ain Shams University
Enrollment
46
Locations
1
Primary Endpoint
The time of the first dose of fentanyl rescue analgesia intraoperative
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mohamed atef

assistant lecturer of anesthesia

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Refusing to participate in the study.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorders.

Arms & Interventions

Study group (IAN block group)

patients will receive bilateral inferior alveolar nerve block. 23 patients

Intervention: bilateral inferior alveolar nerve block

control group

patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol. 23 patients

Intervention: Ketorolac and fentanyl

Outcomes

Primary Outcomes

The time of the first dose of fentanyl rescue analgesia intraoperative

Time Frame: Throughout the surgery

guided by hemodynamic changes

Total amount of additional intraoperative fentanyl rescue analgesia

Time Frame: Throughout the surgery

guided by hemodynamic changes

The time from recovery to the first dose pethidine rescue analgesic

Time Frame: 24 hours postoperatively

guided by visual analogue scale.

Total amount of pethidine postoperative rescue analgesic

Time Frame: 24 hours postoperatively

guided by visual analogue scale.

Secondary Outcomes

  • Incidence of complications related to the block(24 hours postoperatively)

Study Sites (1)

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