A clinical trial to study the effect of two drugs - Lignocaine and Ropivacaine used for giving local anesthesia in ear surgeries

Efficacy and Safety profile of 2% Lignocaine versus 0.5% Ropivacaine as local anaesthetic agent in middle ear surgeries in a tertiary care centre Chengalpattu district - A Single Blind Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081547

Enrollment

Registered

2025-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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 Health Condition 2: 3- Administration Health Condition 3: H652- Chronic serous otitis media Health Condition 4: H661- Chronic tubotympanic suppurative otitis media Health Condition 5: H720- Central perforation of tympanic membrane Health Condition 6: H800- Otosclerosis involving oval window, nonobliterative Health Condition 7: H742- Discontinuity and dislocation of ear ossicles Health Condition 8: H744- Polyp of middle ear

Interventions

Intervention1: 0.5% ROPIVACAINE: 0.5% Ropivacaine (Inj.0.5%ROPIN) with epinephrine (Inj.VASOCON) in the ratio 1:40,000 (20 ml of 0.5% Ropivacaine with 0.5 ml of epinephrine 1:1000) at a dose of Ropiva

Eligibility

Inclusion criteria

Inclusion criteria: Patients with middle ear pathologies planned for surgeries like tympanoplasty, Stapedectomy, mastoidectomy, myringotomy, grommet insertion. Patients those who provided informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.Previous history of Allergic reactions to Amide type local anaesthetics 2.History of severe cardiac arrythmias, severe liver or renal disorders, neurological disorders 3.Pregnancy and breastfeeding mothers 4. Cognitive barriers

Design outcomes

Primary

Measure	Time frame
Postoperative Analgesia using Visual Analog ScaleTimepoint: Every hour till first 8 hours during the postoperative recovery period, Pain will be assessed using Visual Analog Scale	—

Secondary

Measure	Time frame
onset of action of local anaesthesia by pin prick methodTimepoint: time calculated from completion of administration of local anesthesia to onset of anesthesia;duration of action of local anaesthesia assessed by return of sensation in targeted areaTimepoint: in first 8 hours of postoperative period;time of 1st rescue analgesic given postoperativelyTimepoint: in the first 8 hours of postoperative period;surgeon satisfaction by Likert scaleTimepoint: ;patient satisfaction with LOWA satisfaction with anesthesia scaleTimepoint: ;hemodynamic stability by recording the vitals during the intraoperative periodTimepoint: ;adverse effects like Nausea, vomiting, Bradycardia, Hypotension, Dizziness, Confusion, Respiratory depression, seizures, Cardiac arrest will be recorded Timepoint:	—

Measure

Time frame

onset of action of local anaesthesia by pin prick methodTimepoint: time calculated from completion of administration of local anesthesia to onset of anesthesia;duration of action of local anaesthesia assessed by return of sensation in targeted areaTimepoint: in first 8 hours of postoperative period;time of 1st rescue analgesic given postoperativelyTimepoint: in the first 8 hours of postoperative period;surgeon satisfaction by Likert scaleTimepoint: ;patient satisfaction with LOWA satisfaction with anesthesia scaleTimepoint: ;hemodynamic stability by recording the vitals during the intraoperative periodTimepoint: ;adverse effects like Nausea, vomiting, Bradycardia, Hypotension, Dizziness, Confusion, Respiratory depression, seizures, Cardiac arrest will be recorded Timepoint:

—

Countries

India

Contacts

Public ContactSwathi S

Karpaga vinayaga institue of medical sciences and research centre

karthient@gmail.com8056802061

Outcome results

None listed

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