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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Tunisia
Charles Nicole Hospital
RECRUITING
Tunis
Charles Nicolle Hospital of Tunis
COMPLETED
Tunis
Contact Information
Primary
yasmine sanaa, MD
yasmine.sanaa@gmail.com
+21658330834
Backup
Issam Zairi, MD, PhD
przairi@gmail.com
0021697300683
Time Frame
Start Date: 2024-02-06
Estimated Completion Date: 2024-03-04
Participants
Target number of participants: 30
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University Tunis El Manar

This content was sourced from clinicaltrials.gov