A Study Comparing Sedation versus Local Anaesthesia for Reducing Pain During Medical Thoracoscopy

An Open-label Randomized Controlled Trial Comparing the Effect of Conscious Sedation Versus Intrapleural Lignocaine on Pain Score in Patients undergoing Medical Thoracoscopy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096263

Enrollment

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: J90- Pleural effusion, not elsewhere classified

Interventions

Intervention1: Intrapleural Lignocaine: hypoxia, hypotension, arrhythmia, procedure interruption (minimum saturation recorded for 30 seconds & baseline, BP at baseline and minimum & maximum values rec

Eligibility

Inclusion criteria

Inclusion criteria: Indication for diagnostic or therapeutic medical thoracoscopy, Hemodynamically stable patients.

Exclusion criteria

Exclusion criteria: Any contraindication of thoracoscopy, Allergy or contraindication to lignocaine or sedative drugs, Altered mental status or inability to provide informed consent, Bleeding diathesis or INR more than 1.5, Complex or septated pleural effusion on ultrasound, Cutaneous infection, metastasis or rib fracture around port insertion site, Uncorrectable type 1 respiratory failure, Ongoing type 2 respiratory failure.

Design outcomes

Primary

Measure	Time frame
Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded within 20 minutes of the procedure by an independent nursing officer.Timepoint: 20 minutes	—

Secondary

Measure	Time frame
Patient satisfaction score (5-point Likert scale).Timepoint: 20 minutes;Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded before and within 120 minutes after the procedure by an independent nursing officer.Timepoint: Before medical thoracoscopy 120 minutes after procedure;To compare complication rates between the two groups (Hypoventilation, hypoxemia, hemodynamic instability)Timepoint: During or within 120 minutes of procedure;To compare recovery times (time to sit, time to ambulation, time to discharge)Timepoint: NA;To compare operator satisfaction using a numerical rating scale recorded within 20 minutes post-procedure.Timepoint: Within 20 minutes post-procedure.;To compare total doses of analgesics and sedatives used between the 2 groups.Timepoint: NA;To compare the yield of biopsy between the 2 groupsTimepoint: NA	—

Measure

Time frame

Patient satisfaction score (5-point Likert scale).Timepoint: 20 minutes;Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded before and within 120 minutes after the procedure by an independent nursing officer.Timepoint: Before medical thoracoscopy 120 minutes after procedure;To compare complication rates between the two groups (Hypoventilation, hypoxemia, hemodynamic instability)Timepoint: During or within 120 minutes of procedure;To compare recovery times (time to sit, time to ambulation, time to discharge)Timepoint: NA;To compare operator satisfaction using a numerical rating scale recorded within 20 minutes post-procedure.Timepoint: Within 20 minutes post-procedure.;To compare total doses of analgesics and sedatives used between the 2 groups.Timepoint: NA;To compare the yield of biopsy between the 2 groupsTimepoint: NA

—

Countries

India

Contacts

Public ContactDr Ruchi Dua

All India Institute of Medical Sciences

ruchi.pulm@aiimsrishikesh.edu.in7895973469

Outcome results

None listed

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