Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery

Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial

Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.

The main question it aims to answer are:

• Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
• Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?

Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.

The patient:

• Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
• They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.

Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Analgesia; Anesthesia, Local; Mandible Fracture
• Intervention / Treatment: Drug: Bupivacain

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: yasmine sanaa, MD; Phone Number: +21658330834; Email: yasmine.sanaa@gmail.com
• Study Contact Backup: Name: Issam Zairi, MD, PhD; Phone Number: 0021697300683; Email: przairi@gmail.com

Study Locations

• Tunisia
  • Tunis, Tunisia, 1002
    • Recruiting
    • Charles Nicole Hospital
    • Contact: ISSAM M ZAIRI, PhD
  • Tunis, Tunisia, 1053
    • Completed
    • Charles Nicolle Hospital of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
• Proposed for open reduction and internal fixation of their fractures under general anesthesia;
• Having provided their informed and documented consent on a consent form.

Exclusion Criteria:

• Pathological mandibular fractures;
• History of mandibular fractures;
• Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
• Patients suffering from trigeminal neuralgia;
• Dental care performed in the month preceding the trauma;
• Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
• Patients on anticoagulants;
• Porphyrias;
• History of malignant hyperthermia;
• Known allergy to local anesthetics;
• Pregnancy or breastfeeding;
• Severe heart failure;
• Atrioventricular conduction disorders;
• Uncontrolled epilepsy;
• Hemostatic disorders;
• Non-cooperative patients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group BNAI+; Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will receive an inferior alveolar nerve block with bupivacaine. All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours.	Drug: Bupivacain; At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized.
No Intervention: Group BNAI-; Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will not receive an inferior alveolar nerve block with bupivacaine ( control group). All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	questionnaire with a numerical scale (0 - 10)	8 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	questionnaire with a numerical scale (0 - 10)	2, 4 , 12, 24 hours post-operatively
Adverse effects	questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache. The notice of an hematoma or in infection at the site of the injection	24 hours post-operatively
The number of instances of rescue analgesia	We will record the number of instances of rescue analgesia following the description of intense pain for each hemi-mandible group.	24 hours post-operatively

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2024
• Primary Completion (Estimated): March 4, 2024
• Study Completion (Estimated): March 4, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Pain, Postoperative; Fractures, Bone; Mandibular Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: T00000228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No