| CTRI Number |
CTRI/2025/03/081957 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Pain Relief Techniques for Better Recovery After Lung Surgery: A Randomized Study |
|
Scientific Title of Study
|
COMPARISON OF ERECTOR SPINAE PLANE BLOCK WITH INTERCOSTAL NERVE BLOCK FOR POST-OPERTAIVE ANALGESIA IN PATIENT UNDERGOING THORACOTOMY FOR DECORTICATION: A RANDOMISED COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajay Kumar Gautam |
| Designation |
junior resident |
| Affiliation |
king george medical college lucknow |
| Address |
Department of Anaesthesiology and critical care
king george medical college
lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7398099970 |
| Fax |
|
| Email |
ajaygautam73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sateesh Verma |
| Designation |
Additional Professor |
| Affiliation |
king george medical college lucknow |
| Address |
Department of Anaesthesiology and critical care
king george medical college
lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7379837390 |
| Fax |
|
| Email |
sateeshverma24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay Kumar Gautam |
| Designation |
Junior Resident |
| Affiliation |
king george medical college lucknow |
| Address |
Department of Anaesthesiology and critical care
king george medical college
lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7398099970 |
| Fax |
|
| Email |
ajaygautam73@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George medical university Lucknow, Uttar Pradesh India 226003 |
|
|
Primary Sponsor
|
| Name |
king george medical college lucknow |
| Address |
Department of Anaesthesiology and critical care
king george medical college lucknow
|
| 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 |
| Ajay Kumar Gautam |
king george medical college lucknow |
Department of Anaesthesiology and critical care king george medical college lucknow
Lucknow
UTTAR PRADESH |
7398099970
ajaygautam73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King george medical university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To compare post operative pain score and analgesic requirement |
After decortication surgery, the erector spinae plane block or intercostal nerve block will be administered by high frequency ultrasound probe with in-plane approach at T5 vertebrae level. Block will be done at the end of surgery with 20 ml 0.25% bupivacaine injection in ES plane followed by recording hemodynamic parameters, maximum peak expiratory flow rate both recorded preinduction and after extubation at 3,6,12 and 24 hours post operatively and comparing the dose of analgesics paracetamol, diclofenac, or tramadol postoperatively |
| Intervention |
To compare the efficacy of erector spinae plane block |
After decortication surgery, the erector spinae plane block will be administered by high frequency ultrasound probe with in-plane approach at T5 vertebrae level. Block will be done at the end of surgery with 20 ml 0.25% bupivacaine injection in ES plane followed by recording hemodynamic parameters, maximum peak expiratory flow rate both recorded preinduction and after extubation at 3,6,12 and 24 hours post operatively and comparing the dose of analgesics paracetamol, diclofenac, or tramadol postoperatively |
| Intervention |
To compare the efficacy of intercostal nerve block |
After decortication surgery, the intercostal nerve block will be done under vision by operating surgeon. It will be done at three intercostal level- at level of thoracotomy and one level above and below and 5 ml 0.25% bupivacaine injection just before closing thorax at end of surgery followed by recording hemodynamic parameters, maximum peak expiratory flow rate both recorded preinduction and after extubation at 3,6,12 and 24 hours post operatively and comparing the dose of analgesics paracetamol, diclofenac, or tramadol postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 60 years
Scheduled for elective lung surgery requiring a thoracotomy approach.
Ability to provide informed consent.
American Society of Anaesthesiologists (ASA) physical status I-III. |
|
| ExclusionCriteria |
| Details |
Known allergy or contraindication to local anaesthetics used in the blocks.
Pre-existing neurological deficits or chronic pain conditions.
Pregnancy or breastfeeding.
Coagulopathy or use of anticoagulant medications that could pose a risk during regional
anesthesia.
Inability to understand or comply with the study requirements.
Emergency surgeries or surgeries necessitating a different approach (e.g.,minimally
invasive techniques).
History of significant psychiatric disorders affecting pain perception.
Patients with severe cardiovascular, hepatic, or renal dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare quality of postoperative analgesia in USG guided ESPB (Erector spinae plane
block) with open ICNB (intercostal nerve block) in patient undergoing decortication surgery and to compare pain score measured by VAS (Visual Analogue Scale) at 3,6,12 and 24 hours
postoperatively between two group |
4 point assessment at 3,6,12 and 24 hours postoperatively between two group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare required analgesia dose in postoperative period in the both groups
Post operative hemodynamic vitals like blood pressure & pulse rate
Post operative lung function measured by MPEFR Maximum Peak Expiratory Flow Rate
Any other adverse event |
4 point assessment at 3,6,12 & 24 hours postoperatively between two group
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study compares two different pain relief techniques used after thoracotomy (a surgical procedure to access the lungs) to determine which method provides better pain management. Patients undergoing lung surgery were randomly assigned to one of the two pain relief strategies. Researchers assessed factors such as pain levels, opioid consumption, side effects, and overall recovery. The goal was to identify the most effective and safest method to improve patient comfort and outcomes after surgery. |