Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Post-operative pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Bupivacain (Drug)
Outcomes
Primary Outcomes
Post-operative pain
Time Frame: 8 hours post-operatively
questionnaire with a numerical scale (0 - 10)
Secondary Outcomes
- 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)
Investigators
Yasmine Sanaa
Yasmine Moufida Sanaa , MD
University Tunis El Manar