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Comparison of Efficacy of Ropivacaine with or without dexamethasone and Bupivacaine with or without dexamethasone for Local Anesthesia in open reduction and internal fixation of Mandible Fractures: A Triple-Blind Randomized Controlled Trial

Efficacy of Ropivacaine with or without dexamethasone and Bupivacaine with or without dexamethasone for Local Anesthesia in open reduction and internal fixation of Mandible Fractures: A Triple-Blind Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093585
Enrollment
32
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: group 3: efficacy of 4 ml of Ropivacaine (0.75%) mixed with 1 ml of dexamethasone (4mg/ml) given as Inferior alveolar nerve block (2.5ml), Long buccal nerve block (0.3ml) Lingual nerve

Sponsors

divyesh kumar tanwar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with unilateral, isolated, mandibular fractures confined to the dentate segment requiring ORIF through intra oral approach, confirmed clinically and radiographically. Medically fit to undergo surgery under local anesthesia. 4. Willing to provide informed consent and comply with follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Patients with additional facial fractures, bilateral mandibular fractures, comminuted fracture, or fractures which require treatment under general anesthesia. 2. History of allergy to local anesthetics or corticosteroids. 3. Patients with systemic conditions affecting healing, such as diabetes, hypertension, osteoporosis, or immunosuppression. 4. Fractures with significant bone loss requiring bone grafting.

Design outcomes

Primary

MeasureTime frame
1. To evaluate pain levels intraoperatively and postoperatively. 2. Record the duration of AnalgesiaTimepoint: 1. pain levels intraoperatively and postoperatively at 2,4,6,8 hour respectively. 2.Duration of Analgesia- time interval between the onset of anesthesia and the patient?s first request for rescue analgesia

Secondary

MeasureTime frame
1.reduction in post operative extraoral swelling . 2.incidence of Complications 3.Safety Profile of Anesthetic-Steroid Combinations 4.duration of surgical procedure.Timepoint: 1. Swelling: Preoperative swelling will be assessed as a mean of a 4-line measurement using a plastic measuring tape (line 1, gonion to lateral canthus of eye; line 2, tragus to commissure of lip; line 3, tragus to midline in chin; line 4, tragus to ala) and at subsequent follow-ups at 1,3,7th day. 2. Safety Profile: Record any adverse events related to the use of local anesthetics or dexamethasone (e.g., hypersensitivity reactions, delayed healing), infection rate and monitoring vitals. A drug reporting form standardized by the Department of Pharmacology; MAMC will be used to report any adverse drug reactions 3.complication assessment form will be filled to record any anesthesia related or surgery related complications in the patient 4. Duration of surgical procedure will be measured from the incision placement till closure of the incision

Countries

India

Contacts

Public ContactDivyesh Kumar Tanwar

Maulana Azad Institute of Dental Sciences

drsujatam@hotmail.com9654700960

Outcome results

None listed

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