Comparing effects of local injection of bupivacaine with and without fentanyl at the site of surgery in open reduction mandibular surgeries on acute pain intensity and opioid requirement: a randomized clinical trial

Comparing effects of local injection of bupivacaine with and without fentanyl at the site of surgery in open reduction mandibular surgeries on acute pain intensity and opioid requirement: a randomized clinical trial.

A clinical trial with a parallel intervention group, double-blind, randomized, phase two on 44 patients. The sampling method is random. Randomization using a table of random numbers is Random allocation software.

Among the patients referred to Maxillofacial Surgery Department of Imam Reza Tabriz Hospital, who are candidates for open surgery for isolated mandibular fracture, participate in the study. Patients are randomly assigned to one of the groups. In the control group, after the surgery and after the sutures, 2 cc of bupivacaine 0.5% (5mg/ml) solution and in the intervention group 2cc of bupivacaine 0.5% (5mg/ml) solution along with 25 micrograms of fentanyl in the surgical site. After discharge from recovery, patients' pain will be measured every four hours for 24 hours using a ten-point VAS scale. The patient is aware of the existence of two types of treatment, but he does not know which group he is in. The data importers in the relevant checklist are not aware of the type of intervention.

Inclusion criteria: Patients who are candidates for open mandibular surgery, except for comminuted and condylar fractures, Surgery performed by one person, ASA class one and two patients Exclusion criteria: The occurrence of any complications that prevent participation in the study, Hypersensitivity to fentanyl, bupivacaine, and other drugs, The presence of infection in the operation site

Intervention: bupivacaine injection with fentanyl after surgery Control: bupivacaine injection without fentanyl after surgery

The amount of pain

Random sampling will be done among the patients referred to the maxillofacial surgery department of Imam Reza Hospital in Tabriz who is eligible for the study. The randomization method is simple and its unit is the individual. Our tool for randomizing is the random number table. Accordingly, the type of treatment is marked with the code A (bupivacaine with fentanyl) and B (bupivacaine without fentanyl) and will be placed inside the sealed envelopes; Then the envelopes will be placed in a bag and mixed. After that, it will be randomly chosen from the bag and upon viewing the code, the treatment will be given to the patient. None of the patients will be informed about the treatment of another patient.

This study is double-blind, so patients do not know which group they will be in. The researcher who must enter data into the checklist will not know which intervention was conducted. Patients are aware of the existence of two types of treatment, but they do not know which group they belong to.