Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery

NCT ID: NCT06243263

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2024-03-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: 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-

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bupivacain

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Sanaa

Yasmine Moufida Sanaa , MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charles Nicole Hospital

Tunis, , Tunisia

Site Status: RECRUITING

Charles Nicolle Hospital of Tunis

Tunis, , Tunisia

Site Status: COMPLETED

Countries

Tunisia

Central Contacts

yasmine sanaa, MD

Role: CONTACT

yasmine.sanaa@gmail.com

+21658330834

Issam Zairi, MD, PhD

Role: CONTACT

przairi@gmail.com

0021697300683

Facility Contacts

ISSAM M ZAIRI, PhD

Role: primary

Other Identifiers

T00000228

Identifier Type: -

Identifier Source: org_study_id