| CTRI Number |
CTRI/2025/10/096263 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Sedation versus Local Anaesthesia for Reducing Pain During Medical Thoracoscopy |
|
Scientific Title of Study
|
An Open-label Randomized Controlled Trial Comparing the Effect of Conscious Sedation Versus Intrapleural Lignocaine on Pain Score in Patients undergoing Medical Thoracoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Dua |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pulmonary Medicine, All India Institute of Medical Sciences (AIIMS) Rishikesh Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand, India, 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7895973469 |
| Fax |
|
| Email |
ruchi.pulm@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Dua |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pulmonary Medicine, All India Institute of Medical Sciences (AIIMS) Rishikesh Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand, India, 249203
UTTARANCHAL
249203
India |
| Phone |
7895973469 |
| Fax |
|
| Email |
ruchi.pulm@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Dua |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pulmonary Medicine, All India Institute of Medical Sciences (AIIMS) Rishikesh Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand, India, 249203
UTTARANCHAL
249203
India |
| Phone |
7895973469 |
| Fax |
|
| Email |
ruchi.pulm@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Road, Rishikesh, Uttarakhand, India- 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Pulmonary Medicine,All India Institute of Medical Sciences, Rishikesh, Uttarakhand-249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Dua |
AIIMS |
Department of Pulmonary Medicine, All India Institute of Medical Sciences (AIIMS) Rishikesh Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand, India, 249203
Dehradun
UTTARANCHAL |
7895973469
ruchi.pulm@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conscious Sedation Group |
Patient will receive IV midazolam (0.02–0.05 mg/kg) ± fentanyl (0.5–1 mcg/kg) in addition to Local infiltration of lignocaine (1%) at the port site before medical thoracoscopy. ICD will be inserted post-medical thoracoscopy for drainage of residual collection. |
| Intervention |
Intrapleural lignocaine |
Instead of intravenous sedation, the patient will receive lignocaine intrapleurally. A 20 Fr chest drain will be inserted at the site of maximum collection as per ultrasound guidance. The fluid will be drained at the rate of 1L per hour. After confirming sufficient drainage with ultrasound, 3mg per kg lignocaine maximum upto 250 mg mixed with normal saline to make up 20 ml will be injected into the chest drain. The tube will then be clamped for 20 mins and patient will be made to lie down in supine position. After 20 mins the chest drain will be removed and medical thoracoscopy will be performed as per standard protocol. Additional intravenous sedation or analgesics will be allowed at the discretion of the thoracoscopist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Indication for diagnostic or therapeutic medical thoracoscopy, Hemodynamically stable patients.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded within 20 minutes of the procedure by an independent nursing officer. |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction score (5-point Likert scale). |
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. |
Before medical thoracoscopy
120 minutes after procedure |
| To compare complication rates between the two groups (Hypoventilation, hypoxemia, hemodynamic instability) |
During or within 120 minutes of procedure |
| To compare recovery times (time to sit, time to ambulation, time to discharge) |
NA |
| To compare operator satisfaction using a numerical rating scale recorded within 20 minutes post-procedure. |
Within 20 minutes post-procedure. |
| To compare total doses of analgesics and sedatives used between the 2 groups. |
NA |
| To compare the yield of biopsy between the 2 groups |
NA |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Medical thoracoscopy is commonly used for diagnosing and treating pleural diseases, but it often causes procedural pain and discomfort. Conscious sedation improves patient comfort but carries risks such as respiratory depression and hemodynamic instability. Intrapleural lignocaine, administered via a chest drain, may offer effective analgesia with fewer systemic side effects.
This open-label, randomized controlled trial aims to compare the effect of conscious sedation versus intrapleural lignocaine on pain scores in patients undergoing medical thoracoscopy. Sixty-eight adult patients undergoing thoracoscopy will be randomly assigned in a 1:1 ratio to receive either conscious sedation (midazolam ± fentanyl) or intrapleural lignocaine (3 mg/kg). Pain will be assessed using the Visual Analogue Scale (VAS) within 20 minutes of the procedure (primary outcome).
Secondary outcomes include pain at baseline and 120 minutes post-procedure, patient comfort, complication rates, recovery time, operator satisfaction, and biopsy yield. Statistical analysis will follow the intention-to-treat principle.
The study aims to develop a safer and simpler analgesic strategy for thoracoscopy, potentially enhancing patient safety, comfort, and procedural efficiency, particularly in resource-limited settings. |