A study in adults having facial bones fracture surgery under general anaesthesia to compare two injections medicines bupivacaine ( numbing medicine) along with dexmedetomidine (sedative and pain relief medicine)versus bupivacaine alone and to assess which gives better pain relief.

Comparison of Bupivacaine and Dexmedetomidine versus Bupivacaine alone Regional Nerve Block on Perioperative Analgesic requirements in adults undergoing Maxillofacial Trauma Surgery under General Anaesthesia-A Triple Blinded Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098780

Enrollment

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Bupivacaine and Dexmedetomidine: Patients will receive regional nerve block with Bupivacaine and dexmedetomidine [ with the maximum volume of 20 ml of 0.25% of bupivacaine with 1 mcg/kg

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy adult patients (greater than 18 years) requiring ORIF of maxillofacial fractures 2.ASA physical status I or II

Exclusion criteria

Exclusion criteria: 1.Patients with allergy or contraindication to bupivacaine or dexmedetomidine. 2. Patients with severe hepatic, renal or cardiac diseases 3. Pregnant or lactating women 4. Patients with cognitive impairment affecting pain reporting 5. Patients with coagulopathy and bleeding disorders.

Design outcomes

Primary

Measure	Time frame
To compare the time to first rescue analgesia during postoperative period between patients receiving bupivacaine combined with dexmedetomidine versus bupivacaine alone regional nerve blocks in Open Reduction and Internal Fixation for maxillofacial trauma.Timepoint: The time to first rescue analgesia (IV Paracetamol 1g) in the post operative period will be recorded in mins and calculated from the time of placement of incision.	—

Measure

Time frame

To compare the time to first rescue analgesia during postoperative period between patients receiving bupivacaine combined with dexmedetomidine versus bupivacaine alone regional nerve blocks in Open Reduction and Internal Fixation for maxillofacial trauma.Timepoint: The time to first rescue analgesia (IV Paracetamol 1g) in the post operative period will be recorded in mins and calculated from the time of placement of incision.

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Secondary

Measure	Time frame
To compare the total intraoperative opioid usage between the groupsTimepoint: Intra-operatively, after the standard anaesthesia intubation & maintenance protocol, monitoring of total Opioid & NSAID used in mcg/mg during the procedure is done.;To compare the intraoperative heart rate & blood pressure between the groupsTimepoint: Before intubation the baseline parameters of heart rate, non-invasive blood pressure (NIBP) are obtained. Following standard anaesthesia intubation protocol, Heart rate (HR), Mean Arterial Pressure (MAP) intraoperative monitoring will be done every 15 minutes till the end of the procedure.;To compare patient-reported satisfaction with pain control between the groupsTimepoint: At the time of discharge the pain control satisfaction by the patient would be obtained through a 2-point LIKERT scale.;To compare incidence of any adverse effects due to the regional nerve blocks between the groupsTimepoint: The incidence of any adverse effects due to the regional nerve blocks will be assessed from the time of administration of the nerve block till the patient is discharged.	—

Measure

Time frame

To compare the total intraoperative opioid usage between the groupsTimepoint: Intra-operatively, after the standard anaesthesia intubation & maintenance protocol, monitoring of total Opioid & NSAID used in mcg/mg during the procedure is done.;To compare the intraoperative heart rate & blood pressure between the groupsTimepoint: Before intubation the baseline parameters of heart rate, non-invasive blood pressure (NIBP) are obtained. Following standard anaesthesia intubation protocol, Heart rate (HR), Mean Arterial Pressure (MAP) intraoperative monitoring will be done every 15 minutes till the end of the procedure.;To compare patient-reported satisfaction with pain control between the groupsTimepoint: At the time of discharge the pain control satisfaction by the patient would be obtained through a 2-point LIKERT scale.;To compare incidence of any adverse effects due to the regional nerve blocks between the groupsTimepoint: The incidence of any adverse effects due to the regional nerve blocks will be assessed from the time of administration of the nerve block till the patient is discharged.

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Countries

India

Contacts

Public ContactDr B Krishnan

Jawaharlal Institute of Postgraduate Medical Education and Research

krishident@gmail.com9488540931

Outcome results

None listed

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