The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

NCT06167187 | Unknown

• 1 other identifier: FMASU MD94/2023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of complications related to the block

  24 hours postoperatively

Study Arms (2)

Study group (IAN block group)

ACTIVE COMPARATOR

patients will receive bilateral inferior alveolar nerve block. 23 patients

Procedure: bilateral inferior alveolar nerve block

control group

ACTIVE COMPARATOR

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

Drug: Ketorolac and fentanyl

Interventions

bilateral inferior alveolar nerve block 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..

Also known as: IANB

Study group (IAN block group)

Ketorolac and fentanyl 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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine - Ain shams university hospitals

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Ketorolac; Fentanyl

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mohamed Atef, ass.lecturer

  faculty of medicine, ain shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Atef, ass.lecturer

CONTACT

00201065270020; Moahmed.Atef@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 12, 2023
• Study Start: June 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)