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The effect of fentanyl in reducing pain after jaw surgery

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220727055567N1
Enrollment
44
Registered
2022-08-12
Start date
2022-08-03
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of mandible. Fracture of mandible

Interventions

Intervention 1: Intervention group: After the surgery is completed and the sutures are applied, 2 cc of Bupivacaine solution (Exir Company-Iran) 0.5% (5 mg/ml) along with 25 micrograms of fentanyl rou

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Candidate patients for open mandibular surgery Age above 18 years Duration of surgery less than 4 hours Candidate patients for general anesthesia Consent to jaw fixation

Exclusion criteria

Exclusion criteria: Unwillingness to cooperate in the study The occurrence of any complications that prevent participation in the study Hypersensitivity to fentanyl, bupivacaine, and other drugs The patient's lack of satisfaction with intermaxillary fixation after the operation Existence of underlying disease and confounding factor such as: hemorrhagic diseases and coagulopathy, kidney and liver diseases, mental and neurological diseases, obstructive lung diseases, hemostatic disorders and dialysis in patients Addiction to drugs and psychoactive substances and history of drug abuse The presence of infection in the operation site History of taking antidepressants and sedatives and any medicine that changes the perception of pain

Design outcomes

Primary

MeasureTime frame
The amount of pain. Timepoint: Every four hours for 24 hours after surgery. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
The amount of opioid use. Timepoint: Every four hours for 24 hours after surgery. Method of measurement: After surgery, the pain level is measured every four hours for 24 hours. If VAS is higher than 5, Pethidine (Exir Company-Iran) will be injected intramuscularly at the rate of 1 mg/kg. After four hours, if the pain repeats, Pethidine injection at the rate of 1 mg/kg will be repeated. The number of times the patient needs pethidine in twenty-four hours will be recorded.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Nezafati

Tabriz University of Medical Sciences

nezaf2000@yahoo.com+98 44 3344 4598

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026