Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery

NCT06243263 | Recruiting Phase 4

• 1 other identifier: T00000228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Pain; Mandible Fracture; Analgesia; Anesthesia, Local

Keywords

Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  questionnaire with a numerical scale (0 - 10)

  8 hours post-operatively

Secondary Outcomes (3)

• Post-operative pain

  2, 4 , 12, 24 hours post-operatively

• Adverse effects

  24 hours post-operatively

• The number of instances of rescue analgesia

  24 hours post-operatively

Study Arms (2)

Group BNAI+

EXPERIMENTAL

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

Group BNAI-

NO INTERVENTION

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.

Interventions

Bupivacain DRUG

At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized.

Group BNAI+

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (2)

Charles Nicole Hospital

Tunis, 1002, Tunisia

RECRUITING

Charles Nicolle Hospital of Tunis

Tunis, 1053, Tunisia

COMPLETED

MeSH Terms

Conditions

Pain, Postoperative; Mandibular Fractures; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

yasmine sanaa, MD

CONTACT

+21658330834; yasmine.sanaa@gmail.com

Issam Zairi, MD, PhD

CONTACT

0021697300683; przairi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yasmine Moufida Sanaa , MD

Model Details: 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 with bupivacaine.

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 6, 2024
• Study Start: February 6, 2024
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

TU (2)